Patent Docs

Judge Newman Files Appeal with D.C. Circuit

By Kevin E. Noonan --

The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading up to the suspension; see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit"; "Judge Newman Matter Continues"; "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing"; "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman"; "Judge Newman Suspended for One Year by Federal Circuit"; "Judge Newman's Suit Continues";  "Special Committee of the Judicial Council of the Federal Circuit Replies").  Recently, her efforts came to naught, as the D.C. District Court dismissed her suit against her colleagues (see "Judge Newman's Suit Comes to an End") and the Judicial Counsel renewed her suspension for another year (see "Special Committee's Suspension Recommendation Adopted by Federal Circuit; Judge Newman Suspension Renewed").

Judge Newman has tenacity as a strong character trait and this is evidenced by her filing an appeal with the D.C. Circuit Court of Appeals earlier this month.  While the Judge asserted several grounds for challenging her suspension before the District Court (including due process violations and procedural irregularities), her appeal to the Circuit Court has winnowed those challenges to one, that the suspension is unconstitutional, wherein if her brethren wished to remove her from the court the proper avenue was to ask the House of Representatives to impeach her.

The brief extols Judge Newman for her six decades of making contributions to U.S. patent law, turning considerations of her age from a liability to a unique strength (Judge Giles Sutherland Rich is perhaps the only jurist having a longer tenure of such contributions).  These contributions include work with UNESCO, the State Department, work on revisions to the Paris Convention, as an advocate for creation of the Federal Circuit, and of course her forty years on that Court.  During that time, the brief asserts that the Judge has published "over 2,000 majority, concurring, and dissenting opinions," with her dissents "hav[ing] been routinely vindicated by the United States Supreme Court,  . . . as recently as this year."  Providing succinct rebuttal to allegations of intellectual infirmity (the supposed predicate for investigations leading to her suspension), the brief cites "both lay and expert witnesses" attesting to the contrary (she is an "unusually cognitively intact . . . woman" who appears "20 or more years younger than her stated age").  "Nevertheless," the brief maintains, the evidence of the past 18 months show the Judge has been "functionally removed from office" and such removal "without impeachment is wholly inconsistent with the Framers' carefully calibrated system of checks and balances."  Accordingly, Judge Newman argues that either the application of the Disabilities Act in this case or the Act itself is unconstitutional.

The brief sets forth the history of the proceedings that have led to the current situation (substantially as Judge Newman herself has presented them in public fora; see "An American (and Completely Unnecessary) Tragedy") in a narrative peppered in its text and footnotes with factual rebuttals of the alleged facts justifying the Judge's suspension.  The narrative also notes procedural idiosyncrasies if not irregularities, such as her assertion that "[t]his was the first time in the history of the Disability Act that a complaint against a circuit judge which proceeded to the committee investigation stage was kept within the same circuit" ("[d]espite Judge Newman's requests"), suggesting the existence of animus or perhaps a lack of certainty about the strength of the allegations against the Judge.  Addressing her refusal to provide the "hospital records, medical, psychiatric or psychological, and other health-professional records that relate to" the alleged "heart attack" and a "fainting episode," as well as all "hospital records and medical, psychiatric or psychological, or other health-professional records of any treatment or consultation in the last two years regarding attention, focus, confusion, memory loss, fatigue or stamina" the brief provides a simple explanation:  none of the events comprising these "false allegations" ever happened according to Judge Newman so she could not provide evidence that does not exist.  Evincing an inclination to appropriately cooperate, the brief asserts that Judge Newman did provide expert reports by clinicians of her choosing that support her contention that there has been no basis for allegations of diminished mental or intellectual capacity.  Without any rebuttal expert testimony or evidence, the Judicial Council imposed a suspension in September 2023 which was renewed in September 2024 according to the brief (and the records of the proceedings before the Judicial Council).

The brief also provides a short discourse on proceedings before the District Court (necessarily short in view of that court granting the Judicial Council's motions to dismiss), including a synopsis of Judge Newman's arguments relevant to the positions she takes before the Circuit Court.

The brief asserts three bases for the Court to overturn Judge Newman's suspension:

• "First, this Court should invalidate the Disability Act's remedies provision as unconstitutional on its face or provide a limiting construction that renders it constitutional."  This argument is based on limitations to the Disability Act to suspensions for "a temporary basis for a time certain" precluding a judge from being assigned no new cases, as opposed to the total preclusion under Judge Newman's suspension from all cases, including ones for which she has already participated in panels.  "No judicial council has ever issued an order that effectively prevents a judge from performing all judicial functions," the brief contends.

• "Second, assuming the Disability Act is given a constitutional construction, it authorizes only suspensions that are, in the Disability Act's plain words, 'for a time certain' and 'temporary.'"  The current behavior of the Judicial Council of imposing upon the Judge repeated one-year suspensions is contrary to the plain language of the Disability Act and provides a basis for the Circuit Court to reverse the Judicial Council's order according to the brief.

• "Finally, this Court should exercise jurisdiction over Judge Newman's 'as applied' challenges.  In those challenges, she contends that the nature of her suspension violates the Constitution and the Act, and that the Judicial Council proceeding itself violated Due Process of Law because, among other conflicts, its members are fact witnesses."  The district court held it did not have jurisdiction for these allegations under McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S., 264 F.3d 52, 54 (D.C. Cir. 2001), which the brief argues was error.

Regarding Judge Newman's constitutional arguments, the brief sets forth the constitutional status of Article III judges as members of a co-equal branch of the Federal government and the importance of ensuring judicial independence.  One aspect of this status is the capacity and opportunity to "exercise judicial power" (which, if it means anything must include "the ability to perform routine judicial functions such as hearing cases, and ruling on the controversies brought before the court"), the brief citing Supreme Court precedent from 1823 (United States v. Maurice, 26 F. Cas. 1211, 1214 (C.C.D. Va. 1823)) to 2018 (Lucia v. SEC, 585 U.S. 237, 270 (2018) (Sotomayor, J., dissenting)) consistent with this definition.  And from Marbury v. Madison the "exercise of judicial power" has been the exclusive province of the judiciary, specifically "the persons [Judges] to whom is delegated the judicial Power of the United States" (emphasis in brief).  This status and its prerogatives have been consistently applied the brief asserts, citing "historical and modern practice" against "administrative suspensions from judicial office."  And this is precisely what has occurred to Judge Newman who has been prevented under an administrative statute (the Disability Act) from performing any judicial work (not just hearing cases) and that "the entirety of her constitutional 'duties' have been reduced to 'receiv[ing] emails from various court departments, including HR, Circuit Librarians, the Administrative Services Office . . . regarding network outages, server patches, new equipment upgrades, and the new International IT access policy,' and being invited 'to various court-related social events.'"

The history of courts dealing with disabled judges has not been suspension, the brief argues, but providing additional help (inter alia, from other judges in the performance of the work of the court).  Importantly, in earlier instances such additional help was relied upon when a disabled judge could not perform his duties, but the judge retained the capacity to perform those duties when able.  The crux of this portion of the argument is what the purportedly disabled judge chose whether or not to perform those judicial duties; they were not taken from such judges against their will (as has happened here).  "It was well understood that the power to decide whether or not to exercise the judicial office to which one was duly appointed for life rested with the judge himself, and not with his colleagues" according to the brief (the power to remove a judge "derelict in his duties" remained with Congress through impeachment).  Uniform recognition of the constitutional unsoundness of a Judicial Council suspending a judge from the exercise of her judicial office is supported by historical precedent, the brief reminding the Court that "in twenty-six years not a single federal judge was involuntarily suspended from her judicial functions as punishment for any misconduct" (citing the Breyer Report, Implementation of the Judicial Conduct and Disability Act of 1980, Report to the Chief Justice of the Judicial Conduct and Disability Act Study Committee, 239 F.R.D. 116, 143 (Sept. 2006), as well as the history of exercise of the Disability Act in other Circuits).  This history of the exercise of Judicial Council's authority regarding the exercise of a disabled judge's judicial power is one where judges voluntarily decided to temporarily do so.  In addition, the brief notes that even in instances where a judge's power to exercise his judicial office was diminished it did not result in "complete divestiture" of the power to adjudicate cases (citing instances in the Fifth, Seventh, Ninth, and Tenth Circuits; it might be noted that all of these cases involved district court judges).  A good reason for earlier Judicial Council's reticence to do so, the brief contends, is "that such an action traduces the House's sole power of impeachment and the Senate's sole power to try impeachments, and is therefore unconstitutional" (emphasis in brief).

Judge Newman's brief sets out a jurisprudential pathway for the Circuit Court to rule in her favor without totally upsetting the administrative applecart providing a route for fairly  dealing with truly disabled judges.  The brief argues the issue is one of statutory construction to avoid a constitutional question (which was one basis for the decision below, which relied on a narrow construction of the Disability Act to dismiss Judge Newman's facial challenge of the law), citing Dimmitt v. City of Clearwater, 985 F.2d 1565, 1572 (11th Cir. 1993).  The brief calls this a "cardinal principle" under Crowell v. Benson, 285 U.S. 22, 62 (1932), and Commc'ns Workers of Am. v. Beck, 487 U.S. 735, 762 (1988), and paints it as a choice for the appellate panel.  But make no mistake, the brief casts this as a choice, and if the Circuit Court cannot find an amenable way to narrowly construe the Act then it must render a decision regarding it constitutionality the Judge contends.  And, the brief asserts, "the upshot is that under either approach, judicial councils lack the power to suspend a judge from the exercise of all her judicial functions" (emphasis in brief).

The narrowing limitation the brief suggests is to "authorize judicial councils to limit, 'on a temporary basis for a time certain' [under] 28 U.S.C. § 354(a)(2)(A)(i), a judge's docket, but not to completely revoke a judge's ability 'to exercise judicial power.'"  This approach has the advantage, according to the brief, that it would not disturb earlier decisions in other judicial disability cases (where, as Judge Newman's brief asserts other Judicial Councils had not overstepped the scope of the suspensions they handed down), and would be "consistent with judicial councils' long-standing understanding of their own powers as well as statutory and constitutional limits on those powers" (emphasis in brief) (reinforcing the point).  Should the Court take this approach, Judge Newman states that this would "recognize that an order that fully divests a judge from judicial functions is well outside the Act's statutory limits," that the Federal Circuit's Judicial Council had never been "clothed with authority to deprive Judge Newman against her will of the 'power to hear and determine judicially questions submitted,'" and accordingly, the Court should issue a declaratory judgment or injunction on her behalf.

The brief considers the alternative (wherein the Circuit Court does not construe the Disability Act narrowly), which is that the Act is unconstitutional.  This conclusion follows directly from separation of powers principles and that it necessarily involves the Judge's ability to exercise judicial power, which is "the power to perform routine judicial functions such as hearing cases, and delivering judgments."  Permitting unlimited suspensions as has happened against Judge Newman substitutes ("abrogates") an administrative order for the "constitutionally prescribed impeachment process."

The brief then considers the consequences of the Circuit Court holding that the suspension provisions of the Disability Act to be constitutional, and argues that in that case only time-limited suspensions having a definite end date are authorized by the Act under its plain meaning (from the statutory provisions that such suspensions are permitted "on a temporary basis for a time certain" and limited to the judge being assigned no new cases) under 28 U.S.C. § 354(a)(2)(A)(i)).  In this regard, the brief sets out canons of statutory interpretation for a definition that whatever these provisions may mean they do not include the unlimited suspension imposed on the Judge.  Under a plain meaning interpretation, the brief argues that "Judge Newman's suspension from judicial duties must have a definitive end date" and that "[t]he order that permits renewed suspensions until Judge Newman submits to medical testing is therefore ultra vires and in excess of Defendants-Appellees' statutory authority."  (Ironically, the Judicial Council opposes this interpretation because it would permit a judge under suspension to "wait the committee out, thwart the functioning of the Act, and be free and clear of any consequence for ongoing misconduct after a single year."  But even if the Court gives credence to this argument, Judge Newman counters that "it is long-settled that courts are obliged to give statutes their plain and ordinary meaning even where it may lead to unwelcome results," citing Lamie v. U.S. Tr., 540 U.S. 526, 534, 538 (2004).  What the Judicial Council ignores is the fact that, should this occur, the Council's remedy is to refer the matter to the House of Representatives for impeachment proceedings to commence according to Judge Newman.)

Finally, Judge Newman's brief argues that the D.C. Circuit has jurisdiction to consider "as applied" challenges (another basis for the district court's dismissal, relying on McBryde).  This portion of the brief is based on explication of 28 U.S.C. § 357, which the brief argues does not preclude review of all orders issued even if some such issues fall within its proscriptive purview.  This is because there is "a fundamental principle of administrative law" that courts "shall [i.e., must] hold unlawful and set aside agency action . . . found to be in excess of statutory jurisdiction, authority, or limitations" under 5 U.S.C. § 706(2)(C), as held in Cuozzo Speed Techs. v. Lee, 579 U.S. 261, 275 (2016), and Wallace v. Christensen, 802 F.2d 1539, 1551 (9th Cir. 1986) (en banc).  This is the case, the brief argues, even when such an order is "final and not appealable" because the reviewable question remains whether the agency "act[ed] outside its statutory limits," citing SAS Inst. v. Iancu, 584 U.S. 357, 370-71 (2018) (the brief using here the analytical rubrics as set forth in SAS).  As for McBryde, the brief asserts error below because exceptions to that decision include situations where "a long-term disqualification from cases . . . , by its practical effect, affect[s] an unconstitutional 'removal,'" 264 F.3d at 67 n.5 [which is] precisely the situation Judge Newman finds herself in.  McBryde does not empower the Judicial Council to "string[] together and indefinitely extend[] numerous suspensions" as the Judicial Council of the Federal Circuit has done here, Judge Newman argues.  Interpreting McBryde as broadly as the Judicial Council has here and the District Court held below "would leave certain decisions of judicial councils entirely beyond review" the brief contends, citing Weinberger v. Salfi, 422 U.S. 749, 762 (1975).

Without expressly raising the types of extensive due process arguments made below, the brief asserts that "Judge Newman enjoys a right to a judicial review of unlawful agency actions" as do all citizens, even if certain aspects, such as whether the Judicial Council's actions are "arbitrary and capricious," are not available to her.  In the context of interpreting the McBryde decision, the brief argues that the District Court held outside its jurisdiction Judicial Council acts such as refusing to transfer this matter to another circuit, despite the Judicial Council taking on the roles of "witness and adjudicator," and "investigator and litigant," which constituted a due process violation without a remedy from a reviewing court.  Regardless, the brief argues that the McBryde decision has been "overtaken by events" and is no longer good law for what it was advocated by the Judicial Council and applied by the District Court.

As evidenced by Judge Newman's recent public remarks, the Judge apparently has no intention of "going way quietly."  On the contrary, the Judge seems to intend to continue her opposition to suspension by the Judicial Council for as long as it takes or time permits.

Yes, Patent Center Really is that Bad

By Michael Borella --

For most of the last two decades, the U.S. Patent and Trademark Office offered its electronic filing system (EFS), through which practitioners could file patent applications and related prosecution documents, and private patent application information retrieval (private PAIR), through which practitioners could view filed applications.  Both were retired on November 8, 2023 in favor of Patent Center.

Patent Center existed as a "working beta" for a number of years.  This alone is not an issue -- organizations launching new web portals often introduce them with a soft launch so that they can crowdsource their final debugging.  However, the formal cutover to Patent Center thirteen months ago has been a disaster.  And with EFS no longer being available as a backup, practitioners are forced to use a buggy, poorly-designed web application with an unintuitive interface for mission critical activities on behalf of their clients.

Patent Center defects are legion.  According to one collection (which has not been updated in six months), there are 141 reported and unresolved issues with Patent Center.  These range from the merely inconvenient to the highly problematic.  Here, I will describe a handful of the most prevalent, irritating, and disruptive.

Ghost Sessions (the spooky side of staying logged in too long)

Like many web portals, Patent Center downloads a number of scripts to run in your browser when you access it.  However, the client side of the application frequently gets out of sync with the server side.  In particular, the server side may time out your session while the client side thinks that the session is still valid.  This means that the Patent Center user interface will appear to be responsive and will allow you to perform a few tasks before informing you that your session has been logged out.  Or just refusing to respond altogether.  Any work that you have done in such a ghost session is lost and you will need to do it again.

Surprise Logouts (because productivity is overrated)

This issue may or may not be related to the ghost sessions issue.  In some cases, you are progressing through a multi-part transaction with Patent Center and you will find yourself unceremoniously logged out.  Your progress may or may not be lost.  Most annoyingly, these surprise logouts can happen during the penultimate step of a lengthy transaction, right after you hit the "submit" button to file documents, or when paying a fee.  In the latter two situations, it may be unclear whether your submission or payment actually went through.

401 Errors (you shall not pass)

This bug popped up a few months ago and is now remarkably common.  I rarely go a day without getting several of these (I even received one while writing this article).  If you leave a Patent Center session open in a browser tab for a while, it will eventually log you out (on both the client and the server this time) and tell you that you lack authorization to access the site.  That is fine, except that once you have a tab in this state, reloading Patent Center will not work.  Instead, you need to close the tab and open a new tab to get back in to Patent Center.

Progressive Slowdowns (every click feels like an eternity)

Most of us pop into Patent Center to upload and file a few documents, then log out.  However, if you have the misfortune of having to stay in Patent Center for a while to make a number of filings, you will find that each transaction makes the interface a little slower.  Eventually, Patent Center gets unbearably unresponsive and you will need to log out and back in to remedy the situation.  In recent experience, you will notice the slowness after making about 5-10 submissions.  This type of behavior is a symptom of a memory leak -- a bug in which software allocates more and more memory without releasing it properly.

And these are just a few issues.  There are plenty more, such as Patent Center not accepting files with capital letters in its extension (e.g., "file.PDF").  Converting text from uppercase to lowercase is a simple activity taught in computer science 101.  Apparently, the USPTO's new motto is "Innovation starts here, but not if your file name yells at us."

Further, Patent Center had a data breach earlier this year involving private assignment data being made publically available.  The USPTO has "addressed" this breach by shutting down access to assignment data in Patent Center, forcing the public to use its unreliable patent assignment search portal instead.

All these issues may not seem significant to anyone which does not use Patent Center on a regular basis.  But they are.  These problems occur frequently and regularly.  Each time you have to log back into Patent Center or reenter data, you need to spend time.  As in all industries, time is money.  The consequence of a defect-ridden portal in that the USPTO is pushing costs to applicants.  Moreover, it is not hard to believe that a submission has been filed or that a fee has been paid when it has not.  This can lead to loss of rights for applicants and penalties for practitioners.

In an ideal world, the USPTO would be open about these problems, and release a memo along the lines of "We screwed up and here is what we are doing to fix it."  But that has not happened.  Instead, Patent Center stands as a prime example of institutional incompetence.  To be clear, it is not the job of applicants and practitioners to help the USPTO debug its own software -- we have other jobs that are demanding and often require long hours.  The USPTO needs to step up.

Without an efficiently functioning web portal, the USPTO cannot achieve its mandate to protect American intellectual property rights.  If we are lucky, the next USPTO director will take the necessary steps to fix the most significant Patent Center issues early in their term.

An American (and Entirely Unnecessary) Tragedy

By Kevin E. Noonan --

Last month, at the Biotechnology Innovation Organization (BIO) Intellectual Property Counsels Committee (IPCC) conference in Washington, DC, the Honorable Judge Pauline Newman of the Federal Circuit gave a lunchtime address that was different from others she has given at many conferences in the past.  This one was heart-rending, inspirational, and illuminating, the subject being the circumstances and history around her suspension (going on two years now) from her duties and responsibilities on the Court.

Much of what the Judge discussed is public knowledge (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit"; "Judge Newman Matter Continues"; "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing"; "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman"; "Judge Newman Suspended for One Year by Federal Circuit"; "Judge Newman's Suit Continues"; "Special Committee of the Judicial Council of the Federal Circuit Replies"; "Judge Newman's Suit Comes to an End; Special Committee's Suspension Recommendation Adopted by Federal Circuit"; "Judge Newman Suspension Renewed") but the talk was more personal and disclosed more specifics about how Judge Newman experienced the situation as it developed.  It was foreshadowed (in retrospect) by the Court schedule of cases in early 2023 that did not include the Judge on any panel.  Not having any reason to suspect anything untoward was about to occur, the Judge thought she was being given a respite to catch up on her writing opinions on some cases on her docket.  That presumption of collegiality was shattered when, in early March 2023 the Chief Judge visited her in chambers and informed her that she should step down from the bench.  The putative reasons were that she had become incompetent and disabled due to having suffered a heart attack and evinced by fainting in the court hallways.  In Judge Newman's telling, both incidents came as a surprise to her (they never happened).  Nevertheless, the Chief Judge initiated the proceedings to have Judge Newman removed, which resulted in the Judicial Council recommending and the Judge's Federal Circuit colleagues voting unanimously that Judge Newman be suspended.  The Judge voiced surprise that such a vote was unanimous.

It is also well-known that Judge Newman did not accept this verdict and brought suit in the D.C. District Court based on her status as an Article III judge requiring impeachment under the Constitution; that she had been denied due process; and that the asserted predicate bases of the Federal Circuit's action were without merit.  Having lost the suit before the district court, Judge Newman has now appealed, and that process, the Judge estimated, is likely to take a few years to be resolved.

And in some ways that is the point, Judge Newman noted, saying that in every action or statement from the Chief Judge, the Judicial Council, or their Department of Justice counsel in her lawsuit what is mentioned in the first sentence or so is the Judge's age.  Noting that she is 97, the Judge acknowledged that the timetable of the appeal is not favorable, but with characteristic spirit said that if it is resolved within a few years we can all celebrate her centenary (which statement was enthusiastically received).  The Judge also said that her age was likely to be the cause of relative disinterest from Members of Congress and others who may be personally sympathetic but have not taken any action on her behalf.

The Judge spent a few minutes talking about the history of the Court and its beginnings, how it was at first opposed by some (including the ABA) and once established was led by such legal giants as Judges Rich and Markey.  At least some of this history was used as a backdrop to the state of the Court now, and Judge Newman's apprehension that many of her colleagues, and a large part of the patent bar, have been publicly reticent to speak out on the merits or process of her suspension (even if privately sympathizing with her).  The reason for this, Judge Newman posited, is fear -- fear of repercussions from those who have initiated and supported her suspension (analogizing this to the famous Nixon enemies list).  The Judge did not ascribe personal animus to those who have done so, however; pragmatically she attributed her suspension as being motivated by a desire to have a younger jurist appointed to the Court.  But it has not escaped her notice that her opinions have frequently been in dissent, and speculated that there may be some of her colleagues on the Court who would rather not be told they are wrong with the frequency with which she had done so when permitted to do so.

As has consistently been the case, the Judge was the antithesis of the caricature of a declining jurist whose time on the bench has past.  As always, Judge Newman was charming, engaging, entirely on top of the narrative and spoke without any sign of hesitation.  Judge Newman is rightly recognized as one of the "lion(esse)s of the law" she extolled in tribute to her earlier colleagues on the Federal Circuit and her commitment to the court as a venerable institution.  The contretemps of the past two years have been  misguided, unseemly, and regrettable, and while unlikely it is an outcome devoutly to be hoped that rationality and good sense prevails and Judge Newman be restored to the bench where she so evidently belongs.

USPTO Drops Proposal to Change Terminal Disclaimer Practice

By Joshua Rich and Andrew Velzen --

On May 10, 2024, the U.S. Patent and Trademark Office published a Notice of Proposed Rulemaking (NPRM) regarding terminal disclaimer practice.  The proposed rule would have required any terminal disclaimer filed to obviate nonstatutory (obviousness-type) double patenting to include provisions tying the validity and enforceability of the claims of that patent to the validity and unenforceability of each of the claims in the other patent.  The NPRM drew over 300 comments, including a highly critical open letter from former USPTO Directors and others.  Now, in light of the vociferous criticism, much like Drake[1] or Nirvana[2] (or for an older audience, Gilda Radner[3]), the USPTO has said "Nevermind."[4]

The NPRM announced a proposed change to 37 C.F.R. § 1.321 that would have added an additional requirement for a terminal disclaimer to be used to overcome nonstatutory double patenting rejections (in addition to the common ownership requirement).  Namely, under the proposed rule, the terminal disclaimer would also have needed to:

[I]nclude an agreement . . . that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which a terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting rejections in which:

any claim has been finally held unpatentable or invalid as anticipated or obvious by a Federal court in a civil action or by the USPTO . . . or

a statutory disclaimer of a claim is filed after any challenge based on anticipation or obviousness to that claim has been made."[5]

The proposed rule would purportedly "promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by one or more terminal disclaimers to another patent having a claim . . . held unpatentable."[6]

There were a raft of potential problems with the proposed rule, ranging from conflicts with codified law and precedent to policy concerns, as we noted in previous posts.[7]  Following in our footsteps, several former high-ranking USPTO officials (including former Directors) signed onto an open letter to Director Vidal.[8],[9]  In fact, the Directors found the NPRM so inflammatory, that they called for not only a non-enactment of the proposed rule, but also an immediate withdrawal of the NPRM, itself.

The letter argued that the proposed rule was an improper -- indeed, illegal -- exercise of rulemaking authority on two basic grounds.

First, it argued that the proposed rule would constitute a "substantive" rule and, therefore, was beyond the USPTO's statutory authority to implement (i.e., illegal).  Under 35 U.S.C. § 2(b)(2)(A), the USPTO "may establish regulations, not inconsistent with law, which . . . shall govern the conduct of proceedings in the Office."[10]  This is frequently interpreted as giving the USPTO the authority to make procedural rules, but not substantive ones.[11]  Notably, both the proposed rule and former Directors' letter preceded the overturning of Chevron deference by the Supreme Court in Loper Bright Enterprises v. Raimondo.[12]  That decision shifted the ground beneath the USPTO's feet, robbing it of deference in rulemaking, and arguably making the proposed rule even further outside the USPTO's purview.

Second, the Directors' letter argued as we had before that the proposed rule conflicted with the Patent Act because it would render entire families of patents invalid or unenforceable whenever a single claim in an entirely different patent tied to it by a terminal disclaimer was found invalid or unenforceable.  It did not seem like a close question, since 35 U.S.C. § 282(a) requires that:

A patent shall be presumed valid.  Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim.  The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity [emphasis added].

The proposed rule would have turned that presumption on its head and linked the validity of all members of a terminal disclaimer family together.  If one claim had fallen, it would have been an anchor around the neck of all the others, sinking them with it.

The Directors' letter also attacked the proposed rule on policy grounds.  It argued the NPRM relied on an insufficient investigation of the need for the proposed rule and that the proposed rule "seeks to solve a problem that does not exist."  Indeed, even the data presented in the NPRM, itself, seemed to undercut the necessity of the proposed rule.  Furthermore, the letter set forth a parade of horribles that could result as unintended consequences of the proposed rule.

In light of the former Directors' letter (and many other negative comments), the USPTO has now announced that it "has decided not to move forward with the proposed rule at this time and to withdraw the proposed rule," citing "resource constraints."[13]  In a note of grace in withdrawing the proposed rule, the USPTO noted that:

Despite the decision not to move forward with the proposed rule at this time, the USPTO appreciates and takes seriously the thoughtful perspectives raised by commenters.  The USPTO will continue engaging with its stakeholders as it works to foster a balanced, robust, and reliable intellectual property system.

Regardless, the final result is the one suggested by the authors and the former Directors alike:  the withdrawal of the proposed rule requiring changes to terminal disclaimer practice to obviate nonstatutory double patenting.

[1] https://en.wikipedia.org/wiki/Honestly,_Nevermind
[2] https://en.wikipedia.org/wiki/Nevermind
[3] https://www.youtube.com/watch?v=fZLeaSWY37I
[4] https://public-inspection.federalregister.gov/2024-28263.pdf
[5] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting.
[6] https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting
[7] For in-depth discussions of the problems with the proposed rule, see https://www.patentdocs.org/2024/05/uspto-proposed-rule-change-to-terminal-disclaimer-practice.html, https://www.patentdocs.org/2024/05/the-usptos-proposed-terminal-disclaimer-rule-a-litigators-perspective.html
[8] The letter was signed by former directors Andrei Iancu, David Kappos, and Drew Hirshfeld and former deputy directors Laura Peter and Russell Slifer. A copy of the letter can be found here: https://patentdocs.typepad.com/files/2024-05-28-letter.pdf
[9] For an extensive discussion of the letter, please see https://www.patentdocs.org/2024/06/former-directors-request-rescission-of-proposed-rule-change.html.
[10] https://www.law.cornell.edu/uscode/text/35/2.
[11] See also Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996); Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991).
[12] No. 22–451, 603 U.S. __, 144 S. Ct. 2244 (2024).
[13] https://public-inspection.federalregister.gov/2024-28263.pdf

USPTO Institutes Additional Fees for Large Information Disclosure Statement Filings

By Michael Borella and Joshua Rich --

The advice to practitioners faced with marginally relevant prior art has long been "when in doubt, cite it."  There was a small cost for the applicant (or practitioner) to cite such art by filing an information disclosure statement (IDS), but substantial potential risks that could arise if the art was not cited.  On the other hand, examiners had to consider tangentially-related art along with the most relevant art.  The USPTO has now decided to institute a fee for filing large IDSs, which may very well have unintended, adverse consequences for the patent system as a whole.  It will create greater ethical challenges for practitioners and may degrade patent quality.  That is, the USPTO's cure may be worse for everyone involved than the problem has been for examiners.

The duty to disclose prior art on an IDS is unique to U.S. patent law practice.  While some other jurisdictions have prior art disclosure procedures (for example, in Canada, applicants can identify prior art voluntarily or do so in response to an examiner's request) or require identification of co-pending applications in other jurisdictions (such as in India, where the art cited in these applications may be used for evaluation of patentability), the U.S. requirements are both obligatory and more extensive.  As set forth in 37 C.F.R. § 56(a), the duty of disclosure requires that:

Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section [emphasis added].

§ 56(b) adds some clarity on whether art is "material", stating that "information is material to patentability when it is not cumulative to information already of record or being made of record in the application."

The duty applies to a surprisingly large number of individuals -- all patent practitioners (whether in house or outside counsel) working on the application, all inventors, and any other individuals "associated with the filing and prosecution of a patent application."

A failure to discharge the duty of disclosure can have severe consequences for both the patentee (a finding of inequitable conduct can render the patent unenforceable) and practitioners (who can face professional discipline).  That is, the cost of failing to disclose a material, non-cumulative reference is potentially devastating.  Accordingly, it is critical for an applicant to thoroughly disclose all such references.

But the rub with the duty to disclose is that there is no clear definition of what is material to patentability or cumulative.  Both of these terms have a degree of subjectivity, and will be fiercely litigated based on facts unique to each case.  Given that, the aforementioned individuals are incentivized to disclose all known art when filling out IDSs because the cost of an incremental disclosure is far lower than that of even just being accused of inequitable conduct.

The USPTO contends, however, that "[in] many instances, these large IDS submissions contain clearly irrelevant, marginally relevant, or cumulative information."  To battle this perceived problem, on November 20, 2024, the USPTO published its final rule for "Setting and Adjusting Patent Fees During Fiscal Year 2025" in the Federal Register.  While the final rule includes a number of fee increases and new fees, the IDS-specific fees are set forth in Table 10 and excerpted below.

Notably, while Table 10 provides the large entity (undiscounted) fees, the final rule makes no mention of small or micro entity discounts for these fees.  Thus, it appears that the new IDS payment rules are as follows for all applicants:

a first amount ($200) in § 1.17(v)(1) for a cumulative number of applicant-provided or patent owner-provided items of information in excess of 50;

a second amount ($500) in § 1.17(v)(2) for a cumulative number of applicant-provided or patent-owner-provided items of information in excess of 100 but not exceeding 200, less any amount previously paid under § 1.17(v)(1); and

a third amount ($800) in § 1.17(v)(3) for a cumulative number of applicant-provided or patent owner-provided items of information in excess of 200, less any amounts previously paid under § 1.17(v)(1) and/or (v)(2).

The USPTO justifies these fees by noting that "[a]bout 5% of applications contain 51 to 100 applicant-provided items of information, about 4% of applications contain 101 to 200 applicant-provided items of information, and only 4% of applications contain more than 200 applicant-provided items of information."  While this means that the new IDS fees are expected to only impact about one of every eight applications, the USPTO states that it has provided examiners with "approximately 80,000 additional hours each year to consider large IDS submissions in applications, costing the agency $10 million annually."  The USPTO further asserts that "this cost is subsidized generally by patent fees, primarily maintenance fees collected for patents that resulted from applications that did not contain large IDS submissions."

At first blush, this seems to be a reasonable justification for the fees.  However, upon deeper reflection it is not clear how the USPTO has calculated these numbers and whether they reflect actual costs in practice.  For example, it is common practice for applicants to file continuation applications with an IDS citing all art from all parent applications.  This can easily break the new 50-reference limit on free IDSs, especially if the application family has foreign counterparts where art has been cited or is perhaps the 3rd or 4th continuation (or more).

This is less of a burden than meets the eye because the USPTO typically assigns the same examiner to all U.S. applications in a family.  So the majority of references in an IDS for a continuation may have already been considered by the examiner, and the examiner can proceed through the cited references much more quickly than references that are actually new.  If the USPTO's analysis does not take this factor into account, it is misleading and could dramatically overestimate the actual cost of handling large IDSs.

Regarding continuations and the like, the USPTO writes:

The cumulative count is determined for each application or patent separately.  That is, the count from an application does not carry over to any continuing applications, CPAs, reissue applications, or any post-issuance proceedings such as supplemental examinations or reexamination proceedings.  Instead, continuing, CPA, and reissue applications and post-issuance proceedings will start with a count of zero.[1]

This means that references cited in a parent application do not count against any of its child applications unless those references are re-cited in the children.  But the USPTO reiterates its policy that examiners must "consider items of information that were considered in a parent application when examining a child application (e.g., a continuation, continuation-in-part, or divisional application) without any action required on the applicant's part."  It continues by clarifying that "applicants who wish to avoid paying the IDS size fees in a child application for items of information considered in a parent application may do so by not resubmitting the items."  That is, for the examiner, an applicant citing the same references makes essentially no difference in the scope of art that must be considered, but the applicant may face substantial fees for re-citation of those references.

The USPTO's statements suggest a fee-reducing solution for applicants -- do not cite any references in child application if those references were cited and considered in any of its parents.  The applicant will still need to cite any references that were not cited in the parent applications, but that number is likely to be significantly smaller.  The downside to this strategy is that the uncited references from the parent application will not appear on the face of the any patent that issues from the child application.

The value of the cited references being so clearly set forth in the patent is debatable, but it is clear that it provides some benefit.  On one hand, whether references are printed on its face has no material impact on the validity of a patent.  On the other hand, it may be helpful to show a jury (and perhaps certain judges) this crystal clear evidence that the examiner found the issued claims patentable over the references.  And for the public, it provides immediate notice that the cited art was considered by the examiner without requiring a dive into the prosecution history.

To simplify its enforcement of the IDS fee plan, the USPTO is also requiring that "an IDS contain a clear written assertion by the applicant and patent owner that the IDS is accompanied by the appropriate IDS size fee or that no IDS size fee is required."  While "[t]here is no specific language required for the written assertion, . . . it should be readily identifiable on the IDS and clearly convey the applicable IDS size fee by specifying the particular paragraph in § 1.17(v) that applies (e.g., ''the fee due under 1.17(v)(2)''), if any."

The USPTO will update its standard IDS form to incorporate this language, but there is a trap for the applicant.  Unlike other fees, the applicant cannot generally authorize the office to charge the appropriate IDS fee to a deposit account.  Instead, "authorization to charge fees to a deposit account is not a compliant written assertion under the new § 1.98(a) requirement, unless the authorization clearly identifies the particular IDS size fee that should be charged for submission of a particular IDS."

This means that the applicant needs to maintain an accurate count of applicant-submitted references per application.  Doing so is an onerous task that the USPTO is pushing on to applicants.  While there may be software tools to help an applicant do this bookkeeping, these tools are not free and the labor cost of using them is not cheap.  So, for the privilege of paying the USPTO more fees, applicants have do more work.  And the burden will fall most heavily on small and micro entities and lower-cost practitioners who have less ability to spread the cost of calculation over numerous applications.

The USPTO states, to the contrary, that "the fee should not disproportionately impact small and micro entities."  We disagree.  All USPTO fees disproportionately impact small and micro entities.  The largest entities are multi-billion and trillion dollar companies.  While their patent budgets are finite, they are often quite large and can be adjusted for inflation and fee increases.  On the other hand, small and micro entities are often startups, small businesses, or individual inventors.  These entities are self-funded or funded through loans, angel investors, and/or venture capital, and every dollar counts.  Patent filing and prosecution (not to mention inter partes reviews) are significant costs that are harder to absorb than for larger entities.  As a general premise, bureaucracy favors the powerful.  Here, the USPTO's increase in the bureaucratic process required to comply with the duty to disclose will disproportionately impact those with fewer resources.

In any event, what is an applicant to do in light of the final rule and its new IDS fees?  Here are a few concrete suggestions to reduce the impact of these fees and the time-cost of associated labor.

• As noted above, refrain from filing previously-cited art in IDSs in continuations and other forms of child applications.  While doing so results in the references not appearing on the issued patent, they are still of record in the file wrapper of the parent(s).

• The new fees are based on the number of applicant-cited references per application, but not the size of these references.  To the extent that the applicant can cite to longer, more comprehensive references in lieu of multiple shorter references containing the same content, the applicant should do so.[2]  For example, a product manual (if it qualifies as prior art) is often one of the most detailed and relevant references available to applicants and could (in principle) replace several other references that are cumulative.

• Many applicants use third-party prior art search firms.  Applicants may wish to instruct these firms to provide search results for no more than the very most relevant references found.  Applicants have no duty to disclose references of which they are not aware and do not have in their possession.  Of course, this may make the examiner's job more difficult and decrease patent quality, but it is a problem the USPTO is buying for itself.

• Applications with corresponding academic publications may be the type that most easily run afoul of the new fees.  Modern academic papers routinely cite dozens or even hundreds of non-patent literature references.  Some of these are quite lengthy (e.g., book chapters or entire books).  Moreover, it may be difficult for patent practitioners to reasonably determine the relevance or cumulative nature of such references in highly sophisticated, complex sciences and technologies.  Current practice is to cite all references in a corresponding paper in an IDS, and there may not be a way to avoid doing so without incurring more actual cost than the USPTO fees themselves.

• While applicants should avoid citing references of marginal relevance, they need to remember the subjective nature of such an analysis.  When push comes to shove, it is better for both the applicant and practitioner to pay the USPTO a few hundred dollars than risk any eventual patent being found unenforceable due to a known but uncited reference.

In short, there may be steps that applicants can take to minimize the effect of the new fee rules.  But we are going to see prosecution practices change in unpredictable ways that may not benefit applicants, practitioners, examiners, or the public.

[1] Given that the cost of Requests for Continuing Examination (RCEs) are going up significantly, the cost of an IDS citing additional references may factor heavily into whether an applicant files a continuation application or an RCE.  This is another unintended consequence of the USPTO’s fee changes, but it is unclear how it will change prosecution practice.

[2] It should go without saying that the applicant must never engage in gamesmanship, such as combining multiple references into one file and submitting it as a single reference or citing a later-dated, more comprehensive document instead of an earlier publication.

USPTO Director Announces Resignation

By Kevin E. Noonan --

As has been expected, the Director of the U.S. Patent and Trademark Office, the Honorable Kathi Vidal, has announced her resignation.  Deputy Director Derrick Brent will assume her position (at least temporarily) starting in the second week of December.

As Director, Ms. Vidal (at right) has been involved in a variety of efforts unlikely to survive the change in administration and her letter exhibits her awareness of these changing tides.  Her announcement relates her intentions to go back to the private sector.

Regarding her tenure, Ms. Vidal provides praise for the PTO workforce and called the Office during her tenure an "agency of opportunity."  While citing a number of the Office's accomplishments while she was Director she expressly calls out the agency's Strategic Plan Accomplishments Page, the National Strategy for Inclusive Innovation, and National Entrepreneurship Strategy and creation of "the new Office of Public Engagement."  The Office's continuing mission, she states, is "to drive U.S. innovation, inclusive capitalism, and global competitiveness for the benefit of all Americans," and calls for a peaceful and orderly transition" of administrations.

The message itself is set forth below, including her personal e-mail address.

Message to my USPTO friends and colleagues:

It has been an honor and a true joy to be with you on our collective journey these last few years.  Together we have transformed the USPTO.  We have executed on our mission to proactively defend and promote strong intellectual property to lift communities, create better jobs, and foster the American innovative spirit in everyone.  And we have been successful because of our commitment to putting employees first.

Though our work is not done, it is time for me to turn the reins over to Deputy Director Derrick Brent, who has worked alongside me every step of the way.  My last day at the USPTO will be in the second week of December.  I will be moving back into the private sector and working with individuals and companies directly, committed to our same mission.

Know that the work we have done—from weaving employee experience and inclusion into the fabric of our operations, to focusing on the USPTO as not only America's Innovation Agency but as an agency of opportunity—will persist.

Thank you for your dedication, service, and support of one another.  You have challenged me, and each other, to be better.  And you have showed up every day with ingenuity and thoughtfulness to meet that challenge!  You are not only some of the most skilled and innovative people I've ever worked with, you are my friends and treasured colleagues, and I will be forever grateful for your work, which powers our communities and country.

Our record of accomplishments during the Biden-Harris Administration is unprecedented (Strategic Plan Accomplishments Page).  Together we pointed the USPTO in a new direction focused on employees and customers.  We united under the mission to drive U.S. innovation, inclusive capitalism, and global competitiveness for the benefit of all Americans.  We sat at the table with our union representatives to enshrine our people-first approach into updated collective bargaining agreements for Patents and Trademarks employees, and for support staff to come.  And we created the new Office of Public Engagement to expand and strengthen our outreach.  I am very proud of the amazing progress we've made together.

We would not have gotten this far without the strength of our people at the USPTO.  We have developed processes, procedures, and policies to improve the employee experience and inclusion.  Thousands of you contributed to those changes through my small listening sessions, with questions and ideas in the employee portal, and in conversations at events.  And as a result, we were named one of the most inspiring places to work in government this year.  That is an accolade I know I am very proud of and that agency leadership is committed to maintaining.

As we approach the end of the Biden-Harris Administration, please keep up the good work and continue to execute on our mission for innovators and creators.  And please stand ready to work with the incoming administration's team.  As President Biden said last week, the American people deserve a peaceful and orderly transition.

Even though I will be moving on in the next few weeks, I am committed to finding new ways to work alongside and support you, including founding a new ChIPs USPTO chapter, working to foster our alumni network that we launched here together, supporting you through the Patent and Trademark Office Society and the American Association of Patent Judges, advancing our National Strategy for Inclusive Innovation and National Entrepreneurship Strategy, and so much more!

I will remain a click away at [email protected] and will see you on socials.

With gratitude,

Kathi

Teva v. Amneal -- Amneal's Responsive Brief

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.  This post concerns Amneal's response to Teva's arguments in its Opening Brief.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") having these representative claims:

8,132,712:

1.  A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

18.  The use of a dose counter for preventing miscounting in a metered dose inhaler, the dose counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

9,463,289:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall, and
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port,
    the inner wall canister support formation, the actuation member, and the central outlet port lying in a common plane coincident with the longitudinal axis X.

9,808,587:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall,
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, and
    wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

10,561,808:

1.  A dose counter for an inhaler, the dose counter having a counter display arranged to indicate dosage information, a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input, wherein a regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

11,395,889:

1.  An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction, such that the actuator acts as an anti-back drive member when the actuator is in a non-depressed position, and wherein the incremental dose counter further comprises a second anti-back member configured to restrict motion of the output member in a direction opposite to the count direction when the actuator is disengaged from the output member by a bump surface.

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder, and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal, Teva made two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the first question.

Amneal's Responsive Brief

In its responsive brief, Amneal (unsurprisingly) argues that the District Court made the right decision (and to be fair also has the easier argument, in view of the intrinsic tug of the argument that Orange Book-listed patents should, at a minimum, recite the drug product itself, in this case albuterol sulfate).  In its argument, Amneal emphasizes (literally) that FDA's definition of a "drug product" recites "a finished dosage form…that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3 (emphasis added) (in contrast to Teva, Amneal cites the FDA rules rather than the statutory language).  Amneal contends that "the drug substance" is albuterol sulfate per se and not the combination of the drug and the inhaler that is the subject matter of the claims destined to be delisted if the District Court decision is affirmed.  As Amneal states in its argument, "[i]t is undisputed, however, that the Asserted Patent claims do not recite, identify or refer to the drug substance—albuterol sulfate—as a part of the claimed inventions" (at least not expressly).  Amneal argues that, to overcome these infirmities Teva and its amici (actually only two of seven amicus briefs filed) "seek in effect to rewrite the Listing Statute" by changing the plain meaning of the term "claims" therein to mean "reads on any part of" (which is an abbreviated but not entirely unfair characterization).  Teva does indeed argue in its opening brief that the claims of its asserted patents read on its ProAir inhalation device, but that this is analogous to claims for excipients or generic claims that do not recite the species identified as the active pharmaceutical ingredient.  Where Amneal identifies the principle distinction between the parties' positions is in the definition of the term "drug product," as will be set forth herein.  Further, Amneal disputes the need for claim construction because "even if the claims were construed as Teva proposes, the Asserted Patents still would not qualify for listing in the Orange Book" as they do not recite albuterol sulfate as an affirmative limitation therein.

Amneal's brief identifies the legal issue in the appeal as being the proper construction of that portion of the statute that sets forth what must be disclosed in any patent listed in the Orange Book (21 U.S.C. § 355(b)(1)(A)(viii)):

(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—

(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II) claims a method of using such drug for which approval is sought or has been granted in the application.

Amneal's interpretation of this portion of the statute is that it requires any patent listed to be one wherein "there [would] be a reasonable basis to assert that the patent would be infringed by the unauthorized manufacture, use, or sale of the NDA drug" (emphasis added).  The brief sets forth the history of this portion of the statute insofar as it was changed in 2021, purportedly due to an appreciation (evinced by a House committee report) of "the proliferation of device patents submitted under the auspices of the Listing Statute for drug device combination products, including, most commonly, inhalers," which delayed generic entry by an average of 3.4 years.  Relevant to the issue before the Court, Amneal cites the definition of "drug product" in FDA regulations (but not the statute) to require the presence of the drug substance, citing 21 C.F.R. § 314.3:  "Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients (emphasis in brief)."  The statute, on the other hand, defines the term "drug" broadly (according to Amneal) at 21 U.S.C. § 321(g)(1):

(A) articles recognized in [certain compendia]; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

and defines "device" at 21 U.S.C. § 321(h)(1) as:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is — (A) recognized in [certain compendia], (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

As interpreted by the D.C. Circuit, "FDCA prohibits the FDA from treating a device as if it were a 'drug,'" citing Genus Medical Techs. LLC v. United States, 994 F.3d 631, 644 (D.C. Cir. 2021), "even though [Amneal concedes] the term 'drug' is so broadly defined that it linguistically could include a device."  Amneal points out that the District Court held, consistent with the decision by the Second Circuit's decision in United Food v. Takeda Pharm. Co. Ltd., 11 F.4th 118, 134 (2d Cir. 2021), that "the Listing Statute required a drug product patent to claim not just any 'drug,' but specifically 'the drug for which the applicant submitted the application,'" nor did any of the asserted claims to inhaler devices qualify under the statute as a "finished dosage form."

Regarding the requirements for qualifying as a drug product Amneal's brief identifies three:

• "First, it must be a 'patent for which a claim of infringement could reasonably be asserted [against unauthorized] manufacture, use or sale' of the NDA product. 21 U.S.C. § 355(b)(1)(A)(viii).  In other words, it must be infringed by the NDA product.

• "Second, the patent must be a 'drug product' patent, which simply means that it must claim a drug product. 21 U.S.C. § 355(b)(1)(A)(viii)(I) [although this seems to beg the question here].

• "Third, the patent must 'claim[] the drug for which the applicant submitted the application.""

Amneal argues that the second and third requirements act in tandem to require that the patents claim not just any drug product but the approved drug product itself.  Under this interpretation, the Orange Book-listed claims must recite the drug product (here, albuterol sulfate) and as they undisputedly do not the Court should affirm the judgment of the District Court and lift the stay of the injunction compelling Teva to delist these patents.

Amneal argues that Teva's interpretation of these statutory provisions is erroneous, by being contrary to how the term "claims" is interpreted, inter alia, in Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), and Graver Tank & Mfg. Co., Inc. v. Linde Air Prods. Co., 339 U.S. 605 (1950).  Further, Amneal argues that this interpretation would render superfluous the requirement that the patent "claims the drug," contrary to statutory interpretation precedent citing Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020), and Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy, 548 U.S. 291, 299 n.1 (2006) in support for this argument.  Also, Amneal argues, this overbroad reading of the statute would permit listing of patents for "any type of component, regardless of its nature."  While conceding that "adjacent" provisions of the NDA statute permits "NDA applicants to submit information and samples of all components of the NDA drug" in Amneal's view what is permitted to be listed in the Orange Book is more narrow (it "does not broadly permit listing of any kind component patents" (emphasis in brief)).  What is permitted is listing patents of only one kind, those that claim "a drug substance (active ingredient)" under 21 U.S.C. §355(b)(1)(A)(viii)(I), and Amneal argues that "this implies that patents on other kinds of drug components are not authorized," citing Syngenta Crop Protection, LLC v. Willowood, LLC, 944 F.3d 1344, 1361 (Fed. Cir. 2019) (emphasis added).  Amneal objects to Teva's "plug[ging]" the "component" aspect of the definition of the term "drug" into the statute, due to the specificity of the statutory language for "the drug for which the applicant submitted the application."  Citing Genus Medical Techs. again Amneal further argues that "the FDCA prohibits the FDA from treating a device as if it were a drug" and thus ("by extension") the statute should prohibit FDA from listing patents that claim only devices from being listed as if they claimed a drug.

Amneal argues that the plain meaning of the Listing Statute does not authorize listing of "any drug product" (emphasis in brief) but only if the patent "claims the [NDA] drug" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) and further that this interpretation is supported by the legislative history (which indicates "congressional intent to curtail the listing of device component patents specifically").  This interpretation, Amneal argues, is also consistent with FDA's definition of a "drug product," the inclusion of which in the Listing Statute necessarily contains the NDA-approved drug product itself.  (Amneal points out that in other contexts Teva itself argued that "drug product patents must require the presence of the active ingredient to qualify for listing in the Orange Book," citing Warner Chilcott (US), LLC v. Teva Pharms. USA, Inc., No. 18-1241 (Fed. Cir. 2018)).  If a "drug product" requires the presence of an approved drug substance in the product, Amneal argues that a "drug product patent" must also do so (emphasis in brief), and if a drug product patent must also claim the FDA-approved drug, "at a minimum" such a patent "must . . . require the presence of the particular drug substance in the NDA product."

Taken together none of the asserted patents meet these requirements, Amneal asserts.

Turning to Teva's arguments, Amneal asserts they are "both erroneous and problematic" for four reasons: they "stray from controlling black letter patent law" under 35 U.S.C. § 112 and erroneously equating "claiming with being infringed"(emphasis in brief); the interpretation would make superfluous the "claiming the drug" requirement; Teva's arguments "ignore[] FDA's definition of 'drug product'"; and "would open up the Orange Book to patents on any aspect of the NDA product or any component that happens to be found in the NDA product."  So doing would be contrary to the existence of the "powerful exclusionary rights bestowed on Orange Book patents" (naming an automatic preliminary injunction, i.e., the 30-month stay, and automatic permanent injunction for the prevailing NDA holder). Amneal also mentions that requiring Orange Book-listed patents to recite the approved drug product "provides a clear rule that will allow stakeholders to more confidently order their affairs when it comes to the listing of patents in the Orange Book" (elsewhere calling this a "commonsense notion").

Specifically, Amneal argues that the claims in an Orange Book-listed patent must recite the NDA-approved drug, not merely by infringed by the accused generic product as Teva contends, if only because Federal Circuit precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), has acknowledged the statutory requirement that the patent "particularly pointing out and distinctly claiming the subject matter which the inventor . . . regards as the invention" under 35 U.S.C. § 112(b).  Amneal makes a simple and straightforward argument, that because "the words of the claim do the claiming," citing Corning Glass Works v. Sumimoto Elec. U.S.A., Inc., 868 F.2d 1251, 1258 (Fed. Cir. 1989) (emphasis in brief), the absence of those words (specifically, of the NDA-approved drug substance, albuterol sulfate) precludes Teva from properly Orange Book listing the asserted claims.  Once again, Amneal asserts the legislative history of amendments to the Listing Statute to illustrate Congress's concerns, including a direction to the General Accounting Office "to submit data on claims in listed patents 'that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug,'" Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889, 4892 (Jan. 5, 2021).  This history, Amneal argues, also forms the basis for the Court to narrowly construe the Listing Statute, because it "demonstrates [that] these requirements were introduced expressly to preclude Orange Book listing of the very type of device patents at issue here."  This "plain meaning" interpretative analysis is supported by the Takeda case from the Second Circuit and In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 7-8 (1st Cir. 2020), relied upon by the District Court, Amneal argues.  Amneal also cites a 1997 Guidance from FDA "explaining" that "a drug product patent must explicitly 'refer to' the NDA product," where Amneal contends "refer to" be interpreted to mean "recite in the claims" of such a patent.  Teva's arguments that "being infringed" is equivalent to "claiming" is contrary to Federal Circuit precedent, Amneal argues, including Hoechst, and is not supported by the Apotex case, relied upon by Teva.  In that case, Amneal argues, the Court merely held that infringement is a necessary, but not sufficient condition (emphasis in brief), and in any case Amneal contends, statements relied upon by Teva are merely dicta (because they were directed to whether the Federal Circuit had jurisdiction).  Amneal similarly dismisses the relevance of Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 759 (Fed. Cir. 1984), and Teva's proffered interpretation of Takeda.

Amneal further challenges Teva's construction of the Listing Statute as rendering the "claims the drug" requirement to be superfluous and that it is "far more expansive than afforded by a fair reading of the Listing Statute" so as to encompass "any component found in the [approved] NDA product" (emphasis in brief).  Amneal challenges Teva's argument that requiring the "NDA drug substance" to be present would render the "drug substance" category superfluous, because the statute contains two categories of patents:  "A drug substance patent requires only the drug substance per se, whereas a drug product patent requires both the drug substance and some further aspect(s) of the drug product."  And the requirement is not merely for "a" drug but for "the" NDA-approved drug "for which the applicant submitted the application" under 21 U.S.C. § 355(b)(1)(A)(viii)(I), which is also the most unambiguous way of understanding the meaning of the term in the context of the Listing Statute, Amneal argues.

Amneal puts its greatest reliance in this regard on the Genus Medical Techs. LLC case, wherein the Court held that "the FDA is prohibited from regulating as a 'drug' anything that meets the statutory definition of a 'device,' even if that item also meets the definition of a 'drug'" because FDA is prohibited from Orange Book-listing patents that claim only a device, Amneal argues.  ("Teva's interpretation cannot be correct, because it would permit precisely what the FDCA prohibits.")  Devices are not drug formulation "ingredients" (which can be listed under the category as components of a "formulation" or "composition") in Amneal's view.

Amneal also addresses Teva's attempts to overcome ("decouple") the undisputed absence of any mention of the drug substance, albuterol sulfate, from the asserted claims of the Orange Book-listed patents at issue.  Simply put, the proper consequence of this absence is for the Court to recognize that these patents to not "claim" the NDA drug product and thus should be delisted, according to Amneal.

Amneal further argues that its interpretation of the Listing Statute "best aligns" with Hatch-Waxman Act goals regarding the balance between exclusivity for brand drugmaker's NDA-approved drugs (and the "extraordinary" injunctive rights conferred by the statute) and opportunities for generic competition.  Adopting Teva's interpretation of the Listing Statute, on the other hand, would permit "patents having nothing to do with the drug development efforts for a given product" to be listed in the Orange Book "as long as the claimed invention, no matter how inconsequential, was found in some part of the NDA product."  And Teva (in addition to listing the asserted patents in this litigation in connection with 21 different products) retains the right to assert them against generic drugmakers under other subsections of 35 U.S.C.§ 271, albeit without the extraordinary advantages conferred by 35 U.S.C.§ 271(e)(2).

Finally, in this regard Amneal rebuts Teva's "baseless and hyperbolic" policy arguments (which will be discussed in future posts on the two amicus briefs submitted in support of Teva).

Amneal asserts in a separate section of the brief that the claims of any properly Orange Book-listed claims must recite the presence of the approved drug, albuterol substrate, and further that there is no need for claim construction because, on their face none of the listed patents asserted by Teva satisfy this requirement.

Teva's Reply to Amneal is discussed here.

Vascular Solutions LLC v. Medtronic, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

The metes and bounds of how courts should consider indefiniteness under 35 U.S.C. § 112(b) were addressed most recently by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).  Regardless, however, of the Court's attempts to properly construe this portion of the Patent Statute (and the Federal Circuit's attempts to comply with those rubrics), the Federal Circuit's recent decision in Vascular Solutions LLC v. Medtronic, Inc. illustrates once again that in patent law very little is simple or straightforward.  And as set forth below, the Court's decision has led to the District Court judge recusing himself from any further involvement in this case.

The case arose over Medtronic's alleged infringement of forty claims from seven patents owned by Plaintiffs (including Teleflex, which was the name party in the opinion):  U.S. Patent Nos. 8,048,032; 8,142,413; RE45,380; RE45,760; RE45,776; No. RE46,116; and RE47,379; each of these patents descending from U.S. Patent Application No. 11/416,629, filed May 3, 2006.  According to the opinion, the claimed invention was directed to a "coaxial guide catheter that is deliverable through standard guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter."  The structure of these catheters are illustrated in this Figure (annotated by Medtronic's expert):

where the yellow portion was "substantially rigid" and closest to the physician using the catheter (termed "proximal"); the blue portion was reinforced (presumably for stability); and the pink portion was closest to the heart ("distal").  The proximal portion comprised a side opening (in the red circle) permitting "interventional cardiology devices" to be delivered through the catheter to the heart (although this was not the only orientation permitted by the claims, forming the physical basis for the indefiniteness dispute between the parties).  Claims of the '032 and '776 patents are set forth in the opinion as illustrative; italicized language is relevant to the issues before the Court:

The '032 patent:

[Claim 11] A device for use with a standard guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-section and a cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising:
    an elongate structure having an overall length that is longer than the predefined length of the continuous lumen of the guide catheter, the elongate structure including:
    a flexible tip portion defining a tubular structure having a circular cross-section that is smaller than the circular cross-section of the continuous lumen of the guide catheter and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the flexible tip portion being sized having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable;
    a reinforced portion proximal to the flexible tip portion;
    and
    a substantially rigid portion proximal of and connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion,
    such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter with at least proximal portion of the reinforced portion remaining within the continuous lumen of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter.

[Claim 13] The device of claim 11 wherein the substantially rigid portion further includes a partially cylindrical portion defining an opening extending for a distance along a side thereof defined transverse to a longitudinal axis that is adapted to receive an interventional cardiology device passed through continuous lumen of the guide catheter and into the coaxial lumen while the device is inserted into the continuous lumen, the opening extending substantially along at least a portion of a length of the substantially rigid portion.

[Claim 18] The device of claim 11 wherein the substantially rigid portion includes, starting at a from distal to proximal direction, a cross-sectional shape having a full circumference portion, a hemicylindrical portion and an arcuate portion.

'776 patent:

[Claim 25] A guide extension catheter for use with a guide catheter, comprising:
    a substantially rigid segment;
    a tubular structure defining a lumen and positioned distal to the substantially rigid segment;
    and
    a segment defining a partially cylindrical opening positioned between a distal end of the substantially rigid segment and a proximal end of the tubular structure, the segment defining the partially cylindrical opening having an angled proximal end, formed from a material more rigid than a material or material combination forming the tubular structure, and configured to receive one or more interventional cardiology devices therethrough when positioned within the guide catheter,
    wherein a cross-section of the guide extension catheter at the proximal end of the tubular structure defines a single lumen.

The opinion recognizes that the claims of the '032 patent include the side opening as part of the substantially rigid portion/segment, while other claims (such as claim 25 of the '776 patent) recite the side opening as separate and distal to the substantially rigid portion/segment.

Initially the dispute was between Teleflex and QXMédical, LLC (no longer a party in this lawsuit), wherein QXMédical filed for a declaratory judgment of non-infringement and Teleflex counterclaimed.  Claim construction in that case construed the term "substantially rigid" to mean "rigid enough to allow the device . . . to be advanced within the guide catheter."  In addition, the District Court construed the term to mean "1) 'the substantially rigid portion must have a considerable degree of flexibility,' and (2) 'the substantially rigid portion must be rigid enough to push the tubular structure through the guide catheter and into the coronary artery.'"  The opinion does not disclose the outcome of that case, but rather sets forth the proceedings before the District Court between Medtronic and Teleflex here, where Teleflex sued for infringement of the '380, '776, '379, and '760 patents by Medtronic's' Telescope product.  During this litigation, Teleflex moved for a preliminary injunction and applied the construction in the earlier QXMédica case in support.  The District Court denied Teleflex's preliminary injunction motion and proceedings were stayed while Medtronic prosecuted "multiple inter partes review (IPR) petitions [ultimately 15 IPRs]."  While the opinion notes some of the claims were invalidated by the Patent Trial and Appeal Board (PTAB) in these IPRs the asserted claims in this case survived and the PTAB's determinations were affirmed by the Federal Circuit.

At this point in the proceedings, Teleflex followed with another preliminary injunction motion, and in consideration thereof the District Court recognized two groups of limitations with regard to the side opening feature:  "Group One," wherein the opening was part of the proximal substantially rigid portion; and "Group Two," where it was not part of the proximal substantially rigid portion, illustrated by Teleflex by this figure:

The District Court denied this second motion, finding that Medtronic had provided "a strong argument . . . that 'substantially rigid portion' should be construed to mean only that portion of the device that acts as a pushrod."  In its decision, the District Court also found fault with Teleflex's claim construction position, which the court understood would require that "the same device could simultaneously infringe two mutually exclusive claims within that patent" (emphasis in District Court opinion), wherein "the same substantially rigid portion shrinks or grows as necessary to accommodate two mutually exclusive limitations" (emphasis in District Court opinion).  For its part, the District Court rejected both parties' claim construction positions regarding the "substantially rigid" limitation, construing that term to require the side opening to be limited to the proximal portion of the catheter (i.e., the Group One embodiments).  Before ruling on this construction, the District Court took recourse to an independent expert (Andrei Iancu, former director of the U.S. Patent and Trademark Office) to provide a written report to the court on how the term should be best construed.  Also rejecting the parties' arguments (Medtronic's' being that the term was indefinite), Mr. Iancu in his report opined that the proper construction was that "the first proximal section of a multi-section guide extension catheter, that ends where there is a material drop in the overall rigidity of the guide extension catheter at or distally to the proximal end of the coaxial lumen where an interventional cardiology device is inserted"; he expressly rejected Medtronic's' indefiniteness contentions.

The District Court agreed with Medtronic, holding that the two alternatives for the physical embodiments of the term were mutually exclusive and that under Teleflex's construction the same device could be found to infringe these mutually exclusive claims.

The Federal Circuit vacated and remanded to the District Court, in an opinion by District Court Judge Mazzant, sitting by designation from the District Court for the Eastern District of Texas, joined by Chief Judge Moore and Judge Prost.  The opinion begins by asserting that the District Court erred in basing its indefiniteness determination on the claims being "mutually exclusive."  The consequence of the District Court's construction of mutual exclusivity is that "(1) claims in a patent cannot vary in the way they claim the disclosed subject matter, and (2) independent claims must be totally consistent with other independent claims."  The Federal Circuit states that "[c]laiming is not restricted in this way" and that:

"The art of claiming sometimes involves drafting claims in a variety of ways to encompass the disclosed subject matter, so long as the claims themselves inform, 'with reasonable certainty,' those skilled in the art about the scope of the invention," citing Nautilus, Inc. v. Biosig Instruments, Inc.

The opinion instructs the District Court on remand to conduct claim construction on a "clam-by-claim" basis and that "at the claim construction stage, the claims are not necessarily 'mutually exclusive' since each independent claim is a different ordered combination of limitations."

The opinion also rejects the notion that the term "substantially rigid portion/ segment" needs to be consistent across claims.  The Court recognizing this to be a functional limitation the panel holds that a portion of the catheter that is substantially rigid needs to be "substantially rigid enough to achieve some function, citing Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1374–75 (Fed. Cir. 2014).  Thus, as applied here:

In some claims, such as claims 13 and 18 of the '032 patent, the substantially rigid portion/segment includes the side opening.  In other claims, such as claim 25 of the '776 patent, the side opening is distal to the substantially rigid portion/segment.  No matter if the side opening is within or distal to the substantially rigid portion/segment, that portion/segment of the catheter must maintain the substantial rigidity to achieve some function—in this case, the function of allowing the device to be advanced within the guide catheter.

Addressing the requirement for consistency in claim construction under, for example, Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001), and Samsung Elecs. Co., Ltd. v. Elm 3DS Innovations, LLC, 925 F.3d 1373, 1378 (Fed. Cir. 2019), the opinion asserts that its decision clarifies that while the term "substantially rigid portion" must be construed consistently across all the asserted claims, in functional claims such as these "that construction can be a functional construction that does not specify the boundary of the 'substantially rigid portion.'"  And the panel rejects Medtronic's' contention that reading the claims in this way would confuse the skilled artisan, finding the remedy for any such confusion in the recitation of the limitation in each individual claim.  The Court further characterizes as "premature" Medtronic's assertions regarding the effects on determinations of infringement (i.e., that the Court's construction would permit the same device to infringe claims that "measure the boundary" of the term differently which, in view of the preeminent role that claim construction plays in infringement determinations rings somewhat hollow).

It is somewhat ironic that in an opinion written by a District Court judge sitting by designation, the claim construction task mandated by the Federal Circuit can be expected to be more difficult and less straightforward, which is likely to be the consequence of this decision.  In something of an ironic twist, the District Court judge, Chief Judge Patrick J. Schiltz of the District of Minnesota filed a recusal order stating that the court cannot impartially resolve the dispute as the basis for the recusal.  Further, the order asserts that the court "has no idea how to reconcile the facts presented to the court with the Federal Circuit's holding," and "does not believe that it can set aside its previous conclusions to make an impartial determination [it thus being] best that this case be handled by a different judge who can write on a clean slate."  And the District Court judge to whom the case was first assigned, Jerry W. Blackwell, himself recused without explanation on Monday.  The case is now assigned to Judge Nancy E. Brasel.  Chief Judge Schlitz's recusal order goes into additional detail regarding the court's inability to apply the Federal Circuit's ruling to the facts of the case before the court that led to his finding of indefiniteness that was overturned by the Federal Circuit.  While Federal Circuit decisions have no doubt in the past created confusion when remanded to district courts for further proceedings, this case suggests (as have others; see In Defense of the Federal Circuit: A Response to Judge Wood) that at least some of the Court's decisions in recent years have failed to satisfy its Congressional mandate to clarify U.S. patent law.

Vascular Solutions LLC v. Medtronic, Inc. (Fed. Cir. 2024)
Panel: Chief Judge Moore, Circuit Judge Prost, and District Judge Mazzant*
Opinion by District Judge Mazzant
* Honorable Amos L. Mazzant, III, District Judge, U.S. District Court for the Eastern District of Texas, sitting by designation.

Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.  This post concerns Teva's Reply brief answering Amneal's Responsive brief to Teva's Opening Brief on appeal.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") (representative claims for these patents can be found here).

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal Teva made two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the first question.

Amneal's Responsive Brief

In its responsive brief, Amneal (unsurprisingly) argued that the District Court made the right decision (and to be fair has the easier argument, in view of the intrinsic tug of the argument that Orange Book-listed patents should, at a minimum, recite the drug product itself, in this case albuterol sulfate).  In its argument, Amneal emphasized (literally) that FDA's definition of a "drug product" recites "a finished dosage form . . . that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3 (emphasis added) (in contrast to Teva, Amneal cites the FDA rules rather than the statutory language).  Amneal contended that "the drug substance" is albuterol sulfate per se and not the combination of the drug and the inhaler that is the subject matter of the claims destined to be delisted if the District Court decision is affirmed.  As Amneal stated in its argument, "[i]t is undisputed, however, that the Asserted Patent claims do not recite, identify or refer to the drug substance—albuterol sulfate—as a part of the claimed inventions" (at least not expressly).  Amneal argued that, to overcome these infirmities, Teva and its amici (actually only two of seven) "seek in effect to rewrite the Listing Statute" by changing the plain meaning of the term "claims" therein to mean "reads on any part of" (which is an abbreviated but not entirely unfair characterization).  Where Amneal identified the principle distinction between the parties' positions was in the definition of the term "drug product."  Further, Amneal disputed the need for claim construction because "even if the claims were construed as Teva proposes, the Asserted Patents still would not qualify for listing in the Orange Book" as they do not recite albuterol sulfate as an affirmative limitation therein.

Teva's Reply Brief

In Teva's Reply to Amneal initially the brief notes that FDA approved it ProAir HFA as a drug, that the inhaler component is the dosage form, and patents claiming dosage forms must be listed under 21 U.S.C. § 321(g)(1)(D).  And this listing does precisely what the Hatch-Waxman regime intended:  notifying generic drug applicants of the patents that can be asserted in ANDA litigation (i.e., it provides the intended statutory benefit to them).  Teva continues by reasserting the consequences of affirming the District Court, including delisting "any genus patent, any patent that claims some but not all components of a drug product, and any patent that claims one but not all of the active ingredients in a drug product" (emphasis in brief).

Teva further reiterates its positions in its Opening Brief:  that the statutory term "claim" should be interpreted to mean "read on" rather than "recite" (clearly a broader construction that resolves Teva's issue regarding the absence of the NDA-approved drug, albuterol sulfate, from the claims of the asserted patents); in this regard, Teva relies on the same precedent (and arguments) asserted in its Opening Brief.  Teva rebuts Amneal's arguments regarding the definiteness requirement in the statute (35 U.S.C. § 112(b)) as not requiring express recitation of the NDA-approved drug but rather (citing the statutory language) that the claim "inform, with reasonable certainty, those skilled in the art about the scope of the invention," citing Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014).  This requirement would not be necessary, Teva contends,"if the entire scope of a patent were explicitly recited in detail in the claims."  Properly understood, what the statute entails is providing notice of the boundaries of the right to exclude and to define limits," Teva argues, citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1348 (Fed. Cir. 2010) (en banc).

As applied to the Listing Statute, Teva asserts Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373, 1379 (Fed. Cir. 2023), for the principle that claims must be construed based on "not just 'the words of the claims themselves'" but also "the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art," citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (citation omitted).  Teva, in making this argument, seeks (it appears) to refute Amneal's more straightforward argument that the absence of any recitation of the NDA-approved drug in the asserted claims is dispositive.  "'Claim language, standing alone' is not the correct standard of law and is contrary to uniform precedent" Teva asserts, quoting Nature Simulation Sys. Inc. v. Autodesk, Inc., 50 F.4th 1358, 1364 (Fed. Cir. 2022).  "Claim language," Teva asserts, "is a boundary, not a laundry list" and "[a] genus claim unambiguously encompasses every species in the genus without mentioning any one of them."  This is where Teva asserts Amneal errs in its responsive brief.

Teva first argues that its asserted patents "claim" a drug so long as it claims a component of the FDA-approved drug product.  Citing Apotex, Teva argues that "[t]he listing decision thus requires what amounts to a finding of patent infringement [literal infringement, Teva specifies], except that the 'accused product' is the drug that is the subject of the NDA."  Amneal doesn't address this, Teva asserts, and thus its attempts to "make something of the modest distinctions between the scope of a claim and the scope of infringement fall flat."  This conclusion is supported, Teva asserts, by Teva Pharms. USA, Inc. v. Leavitt, 548 F.3d 103, 106 (D.C. Cir. 2008), and In re Actos End-Payor Antitrust Litig., 417 F. Supp. 3d 352, 369 (S.D.N.Y. Sept. 30, 2019).  Teva rebuts Amneal's attempts to distinguish Apotex, construing the language of the statute to support its interpretation (and rebutting Amneal's dismissal of Apotex as dicta because that court's decision was directed to interpreting the Listing Statute to determine whether the case raised a substantial question of patent law for jurisdictional purposes).  Teva also asserts the Jazz Pharma case as supporting its interpretation of the Apotex decision.

On somewhat less firm grounds, Teva argues that a patent that claims a component of an NDA drug claims "the drug" based on the express definition of the term "drug" under 21 U.S.C. § 321(g)(D).  After distinguishing Amneal's (and the FTC's) analogy to construing claims to car brakes to encompass the car itself, Teva argues that "the term 'drug' is expressly defined to include its components" unlike the hypothetical car.  Teva also addresses the distinctions raised by Amneal regarding statutory language to "drugs" and "drug substance" patents and conflicts between them (as well as Congress's amendments to the statute to include as listable drug substance as well as drug patents, citing Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123, 131-32 (2019).  (Indeed, Teva argues that some of these statutory changes were motivated by "a unique requirement to list patents claiming polymorphs" and, accordingly, "not all drug substance patents will also qualify as drug product patents."  Teva states that (incorrectly) Amneal argues that "a patent on a component, including a drug substance, cannot be a 'drug product patent'" where according to Teva's interpretation of the statute "FDA recognizes that there is."  Teva further argues that there is no "incongruity" between there being a broad definition of the term "drug" and the phrase "claims the drug for which the applicant submitted the application" in the statute because (in Teva's interpretation) this merely ensures that an applicant cannot list patents that claim "a" drug but claims the NDA-approved drug product.  But this interpretation "does not rule out patents on the components that are submitted to FDA" which, Teva argues, is the situation here.

Teva also insists that FDA approved its ProAir HFA product as a drug, not a device.  If Amneal (or its supportive amici) believe this is not the proper policy then this is an issue for Congress not the courts, Teva argues, because the statute mandates that FDA treat combination products as drugs "in their entirety" (under a single application whenever appropriate" under 21 U.S.C. § 353(g)(1)(B)).  Contrary to Amneal's argument, Teva asserts that "FDA does not regulate 'the device part' of a combination product as a device on its own [but r]ather, a combination product in its entirety is regulated either as a drug or as a device, and the statutory scheme expressly contemplates that the device parts will sometimes be regulated as drug under  21 U.S.C. § 353(g)(1).  (Indeed, Teva maintains that Congress amended the statute in 1990 to "remove the exclusion of devices and their counterparts to 'facilitate the regulation of combination products,' as drugs," citing Genus Medical Technologies LLC v. FDA, 994 F.3d 631, 644 (D.C. Cir. 2021), and the Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 16(b), 104 Stat. 4511, 4526 (Nov. 28, 1990).

Teva also disputes Amneal's arguments that its interpretation of the Listing Statute renders come provisions to be surplusage.  With regard to the statutory phrase "claims the drug" Teva argues that FDA has excluded "[p]atents claiming packaging, patents claiming metabolites, and patents claiming intermediates."  These patents may indeed raise infringement liability under the infringement clause of the Listing Statute but they cannot raise liability under the "claims the drug" clause, citing Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 759 & n.2 (Fed. Cir. 1997), for patents claiming metabolites, for example.  Nor should the Court find persuasive Amneal's arguments regarding other changes in the statute under the Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889 (2021), codified at 21 C.F.R. § 314.53(b)(1) because, Teva argues, "both the text and the legislative history refute the notion that Congress sought to change listing practices in the significant way Amneal hypothesizes."  Regarding Congress's motivations and directions to the GAO related to this statutory change, Teva disputes Amneal's implications that Congress intended to prevent device patents from being Orange Book listed.  Instead, Teva contends Congress was trying to determine the number of patents claiming the device-drug combination and those claiming the device per se (a heavily nuanced argument that comes perilously close to mimicking Amneal's contentions).  Nevertheless, "[c]urrent regulation and practice is to list precisely the types of patents Amneal complains are at issue here," Teva argues, and (turnabout being fair play) Teva notes that "[u]ntil recently, Amneal itself recognized as much with respect to its patents on epinephrine injection products—which likewise did not mention the active ingredient."

Teva devotes a separate section to its arguments that the asserted patents are properly drug product patents.  This basis for affirming the District Court asserted by Amneal in its responsive brief was not part of the court's legal reasoning below, Teva states (terming it "an afterthought").  Regardless, Teva argues that the argument "cannot be reconciled with the text of either the Delisting Statute or the Listing Statute" (emphasis in brief), inter alia, because "Congress did not provide for delisting patents on the basis that it does not claim a drug product," citing 21 U.S.C. § 355(j)(5)(C)(ii)(I) (and Teva argues the patents ordered to be delisted did claim a drug product by virtue of being combination patents).  (Teva takes the opportunity to disparage the lack of legal reasoning, in its view, the FTC mustered in supporting Amneal's arguments in this regard, explicated in a detailed footnote.)  This portion of Teva's argument reaches the important difference between the parties (and amici): while agreeing that a "drug product" is a "finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients" under 21 C.F.R. § 314, does this definition include mechanical devices used to administer the drug? Teva's answer is expansive:  a patent claims a drug product "if it reads on one or more components of a drug," in this case "whether albuterol sulfate, the propellant, the inhaler device, or the entire inhaler, with its constituent parts."  Amneal contends that whatever else is claimed it must include the drug substance itself:  "because a drug product contains a drug substance, it insists that every drug product patent must expressly recite a drug substance (i.e., active ingredient)."  Teva's argument is bound up with the definitions and legal strictures of the relevant statutes ("the relevant regulation defines a 'drug product' as 'contain[ing] a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3(b) (emphasis in brief)).  In contrast, Amneal's position is a simple and straightforward one:  how can a patent claim a drug product if the claims do not recite the drug substance itself?

Teva also disputes whether its asserted patents are "formulation or composition" patents.  Teva claims they are, relying on FDA rules having "expressly recognized" that metered aerosols can be listed as "finished dosage forms."  Teva cannot rely on FDA definitions for the term "composition" (Teva's brief concedes there isn't one) and falls back on patent law definitions of "compositions of matter" as "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids," citing In re Nuijten, 500 F.3d 1346, 1357 (Fed. Cir. 2007), and Jazz Pharms.  This language indicates that "composition patents" include patents on "composition articles" which easily (for Teva) includes "multiple physical components," citing, of all things, Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013).  Importantly here Teva argues that this use of the term is consistent with how the FDCA statute and FDA regulations use the term "component" with regard to drug products.  And Teva points out that what Amneal (and the FTC) define as a composition (i.e., "a mixture of active and inactive ingredients") is more properly termed a formulation, citing HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 683 (Fed. Cir. 2019), for this distinction (supported in a footnote by reference to the Hatch-Waxman letter, cited by Amneal, to the effect that "a formulation patent as a subcategory of composition patents" at https://www.fda.gov/media/149035/download?attachment.)

The brief then addresses Teva's assertion that at a minimum claim construction is required, which the District Court pointedly did not perform.  Teva maintains its position that "a patent can claim an active ingredient without naming it," citing genus claims as an example (emphasis in brief).  Again here Teva takes the opportunity to denigrate the FTC's position (reminding the reader that it is "an agency with no specialized patent knowledge") that "limitations cannot be imported into the claims" (emphasis in brief), stating that claim construction is needed to ascertain properly whether the limitation is present in the claim in the first place.

Finally, Teva restates its contentions that following Amneal's arguments will "destabilize the Hatch-Waxman regime" because the line drawn to balance the rights of branded drugmakers and their generic counterparts is one for Congress, not the courts to set down, citing PDS Consultants, Inc. v. United States, 907 F.3d 1345, 1360 (Fed. Cir. 2018).  Here, Congress had drawn the line, Teva argues, so that its patents are properly listed.  The brief calls "deeply flawed" arguments by Amneal and certain amici that permitting patents like the ones at issue here to be Orange Book-listed "stifles generic competition."  One reason is, Teva maintains, that "FDA typically takes more than 30 months to review an ANDA, meaning that the [statutory 30-month stay] does not actually delay approval" (although to be fair it cannot be said that the ANDA litigation process under §271(e)(2) accelerates approval, either).  Teva argues that this case illustrates that the current situation does not prevent generic competition because "[m]ultiple generic versions of ProAir HFA are already on the market; the first [being] approved in 2020" and Teva itself is marketing an authorized generic version of its branded ProAir HFA inhaler.  Teva extols the benefits of the Hatch-Waxman regime and its "highly ordered process" in contrast to "chaotic, hurried, and risky preliminary-injunction proceedings" arising from § 271(a) litigation proceedings.  Lost will be the notice provisions provided by Orange Book listing Teva asserts, an outcome warned against by the Association for Accessible Medicines in a comment to FDA stating that "[i]nformation on those device-related patents that 'read on' the approved drug product and that is subsequently listed in the Orange Book would be beneficial to the generic drug industry by allowing the normal pre-approval patent resolution to take place . . . ."

The views of several amici will be discussed in future posts.

Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024)

By Kevin E. Noonan --

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC.

To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.  In this litigation, Teva asserted five Orange Book-listed patents:  U.S. Patent Nos. 8,132,712 ("the '712 patent"), 9,463,289 ("the '289 patent"), 9,808,587 ("the '587 patent"), 10,561,808 ("the '808 patent"), and 11,395,889 ("the '889 patent") having these representative claims:

8,132,712:

1.  A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

18.  The use of a dose counter for preventing miscounting in a metered dose inhaler, the dose counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.

9,463,289:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall, and
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port,
    the inner wall canister support formation, the actuation member, and the central outlet port lying in a common plane coincident with the longitudinal axis X.

9,808,587:

1.  An inhaler for metered dose inhalation, the inhaler comprising:
    a main body having a canister housing,
    a medicament canister, which is moveable relative to the canister housing and retained in a central outlet port of the canister housing arranged to mate with a canister fire stem of the medicament canister, and
    a dose counter having an actuation member having at least a portion thereof located in the canister housing for operation by movement of the medicament canister,
    wherein the canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall,
    wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, and
    wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

10,561,808:

1.  A dose counter for an inhaler, the dose counter having a counter display arranged to indicate dosage information, a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input, wherein a regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

11,395,889:

1.  An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction, such that the actuator acts as an anti-back drive member when the actuator is in a non-depressed position, and wherein the incremental dose counter further comprises a second anti-back member configured to restrict motion of the output member in a direction opposite to the count direction when the actuator is disengaged from the output member by a bump surface.

The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder, and granted an injunction compelling Teva to delist these patents.  Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.

On appeal, Teva makes two arguments:  the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the  first question.  That first question is the more difficult one, to the extent to which Teva must convince the Court that the 1st Circuit erred in the Lantus decision and the District Court erred in interpreting the 2nd Circuit's decision in the Takeda case, both of which were decided consistently with the decision against Teva by the District Court.

With regard to its statutory construction argument, Teva maintains that not only did it comply with the listing statute but that it was compelled by the statute to do so.  "A drug product patent must be listed in the Orange Book for a specific NDA (i.e., a brand-name product) if the patent 'claims the drug for which the applicant submitted the application'" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) according to Teva's brief.  This argument can only be persuasive should "the drug for which the applicant submitted the application" be interpreted to encompass per se the inhaler device (and related administration-related accoutrement and not need to include express recitation of the drug administered thereby).  That interpretation further depends on the Federal Circuit being persuaded that the drug itself is impliedly contained in the claims to the "drug product," as interpreted by Teva, analogously to recitations of either genus claims to particular classes of drugs or more broadly to formulation claims reciting excipients and the like.  Teva argues that accepting the arguments by Amneal (and their supportive amici) would greatly reduce the number of Orange Book-listed patents in ways that would harm the careful "balance'" struck under the Hatch-Waxman framework in disclosing to generic competitors (and the public) what patents could be asserted against ANDA-seeking drugmakers under 35 U.S.C. § 271(e)(2).

According to Teva, the District Court erred in what it means to claim a drug product, focusing not on that is recited in the claim but what generic drug product would be adjudged to be infringed.  In the context of Orange Book listing, Teva argues that under the statute, that definition "includes not just an 'article' that treats an illness or affects the body's functioning, but also any 'component' of such an 'article'" under 21 U.S.C. § 321(g)(1)(B)-(D).  This is because "FDA's rulemaking expressly contemplates that patents claiming a 'dosage form' will be listed in the Orange Book and identifies 'metered aerosols' like those at issue here as one example of a 'dosage form.'"

The brief relies on this definition of the term "drug" in the statute:

(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

21 U.S.C. § 321(g)(1) (italics emphasizing the portion of the statute expressly relied upon by Teva).  This definition is both "express" and "expansive," Teva argues, and applies to the listing statute as well, according to the brief.  Teva acknowledges that mere packaging cannot be listed but contends that its inhalers are part of the approved "finished dosage form" of the approved product and therefore the asserted patents to such inhalers et al. were properly listed.  Inclusion of subsection (D) above "ensures that the term 'drug' will reach the entirety (any 'component') of any drug product (any 'article[]' used to treat disease)," Teva argues.

Relying on FDA regulations (68 Fed. Reg. 36,676, 36,680 (June 18, 2003)), the brief asserts that metered aerosols are "expressly categorized" as a dosage form, wherein 'drug delivery systems used and approved in combination with a drug'—a category that includes 'metered dose inhalers'—are distinguishable from the type of 'packaging and containers' that are not properly listed in the Orange Book," Teva citing Orange Book, Appendix C, at C- 1 (44th ed. 2024) in support for this argument.  Moreover, Teva argues that "FDA classifies MDIs [metered dose inhalers] like ProAir as "single-entity combination products," meaning a drug and a device "combined or mixed and produced as a single entity," wherein "[c]ombination products 'constitute a combination of a drug, device, or biological product'" under 21 U.S.C. § 353(g)(1)(A)" that are "regulated either as a drug or a device" under 21 U.S.C. § 353(g)(1).  Regarding MDIs, Teva argues that FDA has classified them as "drug-device combination products for which 'the primary mode of action . . . is attributable to the drug component,'" citing FDA guidance from 1993 (which states that "an aerosol delivery device will be considered a drug product . . . when the primary purpose of the device is delivering or aiding in the delivery of a drug and the device is distributed with the drug").  (This determination also applies to dose counters according to the brief.).  In this way Teva contends the Court must treat the inhaler as it would an excipient or other component of a drug formulation covered under the statute and relevant FDA regulations because that is how FDA approved the combination.

The District Court, in Teva's telling, erred in ruling that the asserted claims must be delisted because none of those claims expressly recited the active ingredient of the drug product, albuterol sulfate, and did so without claim construction (despite the decision depending on whether the drug was claimed in any of the asserted claims).  The brief also asserts that the District Court apparently vacillated "between stating that the claims must recite the active ingredient and stating that the claims must recite the full product itself," finally resting on the purported need for the claims to recite expressly albuterol sulfate.  But Teva asserts another interpretation of the District Court's holding would require a properly Orange Book-listed patent would need to "recite every aspect of a drug (active ingredients, inactive ingredients, excipients, etc.)" which would permit listing only of "claim[s] with limitations explicitly directed to every part of the drug product [that] would satisfy the opinion," which would be "a dramatic narrowing of the scope of the Listing Statute and contrary to established law, citing in this regard Cadence Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1369 (Fed. Cir. 2015), as an example.

Teva asserts that the statute requires that its claims must, under 21 U.S.C. § 355(b)(1)(A)(viii), claim "the drug for which the applicant submitted the application" and the test for whether this is the case is if the accused product would infringe the asserted claims ("The scope of what a patent 'claims' is effectively coterminous with the products that infringe a patent.").  "Critically," the brief asserts (and this is the crux of whether Teva will be successful before the Federal Circuit), a "patent need not read on the entirety of a product to 'claim[]' the product," citing SunTiger, Inc. v. Sci Rsch. Funding Grp., 189 F.3d 1327, 1336 (Fed. Cir. 1999)("[i]f a claim reads merely on a part of an accused device, that is enough for infringement"), "[n]or, in the case of pharmaceuticals, must a patent recite the active ingredient by name in order to claim the drug" (basing this assertion on generic claims "whose active ingredient is one species within the genus," citing In re Omeprazole Patent Litig., 536 F.3d 1361, 1365-66 (Fed. Cir. 2008), and Indivior Inc. v. Dr. Reddy's Lab'ys, S.A., 930 F.3d 1325, 1349-50 (Fed. Cir. 2019)).  Thus, Teva argues that the Federal Circuit has held that a patent that "'claims the drug for which the applicant submitted the application'—and therefore 'must be listed'— if it contains a product claim that reads on the drug that is the subject of the NDA,'" citing Apotex, Inc. v. Thompson, 347 F.3d 1335, 1343-44 (Fed. Cir. 2003).  And under 21 U.S.C. § 321(g)(1)(D), that would include the claims Teva asserted before the District Court (because the term "drug" "covers the entirety of the drug product and any component thereof—not just the active ingredient").  This is because, Teva argues, the FDA-approved "drug product" is the ProAir HFA (the device in combination with albuterol sulfate) -- and "[t]he statutory scheme treats combination products like ProAir HFA as drug products where—as is the case with ProAir HFA—the product's 'primary mode of action' is that of a drug" under 21 U.S.C. § 353(g)(1)(D)(i).

The two "out-of-circuit" cases the District Court relied upon for its contrary determination -- United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co., 11 F.4th 118 (2d Cir. 2021), and In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020) – either actually supported Teva's position (Takeda) or were wrongly decided (Lantus), the brief asserts.  In the former case the court used an "infringement-type [judicial] analysis," which Teva argues was required but not performed by the district court.  And the latter case (as did the District Court here) equated "claims" for a drug with "mention[ing]," the drug in the claims, which is Teva's basis for asserting error.  The brief also notes that these were both antitrust cases, not patent cases, and as such did not address patent-specific issues important in this case.  In Takeda, according to Teva, the Second Circuit adopted the approach Teva espoused, that "a patent claims any product that falls within the bounds of the claim—a determination that must be made through an infringement-type analysis."  And that case was directed to a combination product, with the Second Circuit holding that a patent on only one component of the combination did not "read on" the approved drug comprising the combination.  Regarding Lantus, which held that "if a patent 'do[es] not mention the drug for which the sNDA was submitted, the patent does not "claim the drug" under the Listing Statute,'" the District Court also did not perform claim construction.  Moreover, Teva's brief contends "Lantus's reasoning is inapplicable by its own terms to Teva's claims directed to the entire inhaler product [because the] patent at issue in Lantus did 'not include a claim for an injector pen more broadly,' but rather 'mention[ed] that the drive mechanism is intended for use in a "drug delivery device"'" and in that case the listed claim, despite claiming "a device intended for use as an injector pen [did] not claim any injector pen" (rather it claimed merely a component part of the injector pen).  In this case, "three of the Asserted Patents plainly claim the entire inhaler . . . and thus claim the equivalent of the injector pen—precisely what the court in Lantus thought was missing."

At a minimum, Teva argues, the District Court's decision was error because it was decided on the pleadings and not properly supported by claim construction, because the listing question is one of patent law needing "ordinary claim construction principles" to be applied in making a determination whether an accused infringing product infringes (and there is more to this analysis than "whether a claim name-checks the active ingredient or the drug" according to the brief).  The brief cites several Federal Circuit decisions and those from other circuit courts, including Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373 (Fed. Cir. 2023); Biogen Int'l GmbH v. Mylan Pharms. Inc., 18 F.4th 1333, 1336 (Fed. Cir. 2021); Teva Pharmaceuticals USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008); Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1080 (D.C. Cir. 2001), for the primacy of this principle.  Teva argues that the asserted claims in fact contain terms that encompass the active drug -- albuterol sulfate -- including "[a]n inhaler for metered dose inhalation" recited in the '289 and '587 patents; "medicament canister" recited in the '289, 587, and '712 patents; "an inhaler" recited in the '808 patent; "a metered dose inhaler" recited in the '889 and '712 patents; and "cannister" recited in the '889 patent.

These errors by the District Court require the Federal Circuit to vacate the judgment and remand for further consideration, Teva argues.  Further Teva asserts that this would pose no burden on the District Court, which is construing claims in these patents during the litigation that has proceeded on other grounds not affected by the order to delist.  And doing so would help clarify circumstances like this under the Hatch-Waxman framework, Teva argues, which is beneficial because it "facilitate[s] a scheme that allows the parties to obtain patent certainty before the launch of a drug, thereby supporting the development of both brand and generic medicines" (emphasis in brief); without doing so the consequence of the District Court's decision will result in "significant uncertainty and risk" because "many more infringement disputes would be resolved only after launch of a generic product, including preliminary injunction proceedings, a post-launch jury trial, and an award of money damages."

Teva concludes these arguments by imploring the Federal Circuit not to "disrupt" the balance struck by Congress that "[a]ll drug product patents must be listed in the Orange Book for every drug they claim, for as long as a claim of infringement can reasonably be made under those patents," and that "[t]raditional Paragraph IV invalidity and noninfringement challenges to those listed patents provide an expeditious pathway toward patent certainty."  It must be said that the highest burden towards that end will be the ineluctable lure of the more simple-minded concept that claims not reciting the drug product should not be Orange Book listed, regardless of the nuances found in Teva's explication of the statute and FDA ruled implementing its provisions.  The arguments against such statutory interpretations, by Amneal and almost all the amici, will be set forth in later posts.

Supreme Court Denies Certiorari in Cellect v. Vidal

The Supreme Court issued an order this morning denying certiorari in Cellect, LLC v. Vidal.  A review of the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision can be found here and here.

In re Cellect in View of Supreme Court's "Long Conference" – Part II

By Kevin E. Noonan --

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision.  While that Court's recent Allergan USA Inc. v. MSN Laboratories Private Ltd. opinion may have made the issues (and whether the Supreme Court grants cert) less urgent, the pending U.S. Patent and Trademark Office (PTO) proposed rules limiting terminal disclaimer practice for overcoming obviousness-type double patenting and the permissible scope of those rules by an administrative agency after Loper-Bright Enterprises v. Raimondo continue to garner interest regarding whether the Court will take up review of this decision.  Last week, we reviewed the decision and arguments of the parties.  Today, we review the seven amicus briefs that were filed on behalf of Petitioner and the brief filed on behalf for Respondent.

Amici for Petitioner:

NYIPLA:  provided three Questions Presented that ask the Court to consider "whether [ODP] can [properly] vitiate Congressional guarantees of timely patent examination"; whether the Federal Circuit erred in creating a "rigid rule [that] eliminated all equitable considerations [regarding ODP] and ignoring binding precedent"; and whether ODP was abrogated by Congress enacting legislation conforming U.S. patent law with the URAAA/TRIPS provisions regarding patent term?

The brief asserts that the Federal Circuit in its Cellect decision "usurped Congress's authority [by] abrogating [the statutory patent term] guarantees" and "rejected ODP's equities as well as "significantly adversely impact[ing] innovation."  Significantly, the brief provides this table showing the effects of PTA on U.S. patents from 2015 to 2023:

While providing an erudite and thorough discussion on ODP, its origins, and equitable character, the brief makes its most significant arguments with regard to the importance of the Court granting cert., including that "It has been almost a century since the Court substantively addressed double patenting, and in the interim Congress has significantly amended the Patent Code at least five times."  Additionally, amicus argues that the Cellect decision will have widespread impact (based inter alia on the data set forth above) and in the NYIPLA's view that the Cellect decision "destroys" the guarantees regarding patent term embodied in the statute.  Indeed, amicus argues that "it is time to retire ODP" in view of the changes in U.S. patent law that have made irrelevant the equitable motivation for the doctrine stemming from the potential for serial filings that would award serial 17 year patent terms on patentably indistinct versions of an invention.

AIPLA:  argued that the Cellect decision was an improper expansion of ODP to override statutory PTA, based on statutory construction (plain meaning) and amounting to a violation of the clear intent of Congress.  PTA is not an unjust extension of the patent term but a statutory restoration of term lost due to PTO delay.  The brief notes the structure of the patent term provisions of the statute, wherein § 154(a)(2) defines 20 year term; § 154(b) restores loss of term cause by PTO delay, with § 154(b) being entitled "Adjustment of Patent Term" and § 154(b)(1) being entitled "Patent Term Guarantees."  The brief performs some dictionary-based semantics on meanings of "adjust" and "extend" and asserts that "[p]ut simply, there is no unjust extension of term by PTA, but rather recovery of unjustly lost term due exclusively to PTO delay," stating that the Federal Circuit "conjured" Congressional intent contrary to these provisions of the statute.  With regard to the crux of the Federal Circuit's construction of the statute, the AIPLA maintains that § 154 "does not address ODP" and § 154(b)(2)(B) does not relate to ODP but rather "provides a commonsense limitation on PTA:  if an applicant has already specified a patent's expiration date by disclaiming some amount of term (a 'terminal disclaimer'), the applicant may not go beyond that date [by obtaining PTA]."  The Federal Circuit erred by implicating ODP in the application of § 154(b)(2)(B) because terminal disclaimers are purportedly "two sides of the same coin" (even as here under circumstances where TD not filed, although to be fair the basis was that a TD should have been filed).  The Court's analysis was error because it violates the "strong presumption" of congressional intent not to be rebutted except under "rare and exceptional circumstances," citing United States v. Clintwood Elkhorn Mining Co., 553 U.S. 1, 11 (2008) (quoting Ardestani v. INS, 502 U.S. 129, 135 (1991)). Here, the brief argues that Congressional intent can be found in the language that the Office shall provide PTA to restore term lost due to PTO delay, citing Smith v. Spizzirri, 144 S. Ct. 1173, 1177 (2024) (quoting Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 35 (1998), and Petrella v. MGM, 572 U.S. 663, 685 (2014).  The brief also asserts that the Federal Circuit raised a "negative inference" which is improper under circumstances of having a "limited exception" which is itself improper:  "voluntarily surrender of statutorily granted PTA via a terminal disclaimer does not mean that Congress intended to nullify PTA entirely by exposing PTA-adjusted patents, where no terminal disclaimer is filed, to ODP."  The brief contends that this is not a case of the Federal Circuit "unearth[ing] Congress's hidden intent" but rather that the Court "just rewrote the statute."

The brief also characterizes the decision as being a departure from the equitable underpinnings of ODP, because that doctrine was meant to limit patent term mischief and thus requires a showing of such mischief.  The basis is not just an extension of the patent term but an unjust extension, whereas PTA was intended to do exactly the opposite: restore deserved patent term lost due to USPTO delay.  The brief accuses the opinion of "gutt[ing] [the ODP] doctrine" of its equitable purpose (citing inter alia Immunex Corp. v. Sandoz Inc., 964 F.3d 1049, 1059 (Fed. Cir. 2020), for declaring ODP to be an equitable doctrine) and that prior ODP jurisprudence was directed towards preventing gamesmanship under Abiomed, Inc. v. Maquet Cardiovascular LLC, Civil Action No. 16-10914-FDS, 2023 U.S. Dist. LEXIS 104095, at *101 (D. Mass. June 15, 2023); Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170, 214 (D.N.J. 2021); and Abbott Lab'ys v. Lupin Ltd., No. 09-152-LPS, 2011 U.S. Dist. LEXIS 53846, at *26-27 (D. Del. May 19, 2011), on the basis of unjust extension (there being no evidence of gamesmanship here).

The brief also notes that the opinion discards the equitable requirements in favor of a "bright line rule" (which might resonate with the Court as the strongest argument for granting cert if history be our guide) and that some cases in the district court have already opined that "ODP depends solely on patent expiration dates and should not [be] influenced by equitable concerns," citing Allergan USA, Inc. v. MSN Lab'ys Priv. Ltd., No. 19-1727-RGA, 2023 U.S. Dist. LEXIS 172641 (D. Del. Sep. 27, 2023), later reversed by the Federal Circuit (by the same panel thar decided Cellect) as well as Ex parte Clantech, Inc. (PTAB 2024) and ACADIA Pharm. Inc. v. Aurobindo Pharma Ltd. (D. Del. Dec. 13, 2023).

As to the consequences of the decision and the need for the Supreme Court to apply correction, the brief states that the decision has created uncertainty, upset settled expectations, harmed and innovation.  The magnitude of the possible implications is raised in the brief by citation of a law review article by Mark A. Lemley & Jason Reinecke, Our More-than-Twenty-Year Patent Term 1, 14-15 (Stanford L. & Econ. Olin Working Paper No. 586, 2023), https://ssrn.com/ab-stract=4529670 regarding the high frequency of patents obtaining PTA having an average of 411 days (some even longer) as well as the burden of monitoring patent estates "claim by claim" to avoid invalidation and the current increase in terminal disclaimer filings.

Intellectual Property Owners (IPO):  In a brisk nine pages the IPO's brief emphasizes the Congressional mandate that the term of a patent shall be extended if PTO delay causes term to be lost under § 154(b)(1)(A).  "Congress intended these patent term adjustments to be mandatory, not permissive," according to the brief, relying, inter alia on the "black letter law" meaning of the word "shall."  It was legal error for the Federal Circuit to "in effect[] overrule[] the statute enacted by Congress based on a judge-made doctrine."  This assessment of the Court's error is supported by the Supreme Court's decision that "applied a traditional principle of statutory construction to the Federal Arbitration Act ("FAA") and determined that a judicially-created exception to an FAA provision could not stand," citing Henry Schein, Inc. v. Archer & White Sales, Inc., 139 S.Ct. 524, 530 (2019).  The brief also notes that the Federal Circuit came to the opposite conclusion (i.e., that ODP could not overrule a statute, § 156), in Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1375 (Fed. Cir. 2018).

Terminal disclaimers in the PTA regime are "very clear[ly] defined" to have but "a limited role" in the statute:  firstly, it is the sole exception to PTA in the statute and accordingly, the scope of the exception should be limited, the brief citing United States v. Johnson, 529 U.S. 53, 58 (2000), for the principle that "[t]he proper inference . . . is that Congress considered the issue of exceptions and, in the end, limited the statute to the ones set forth."  The Federal Circuit's error in IPO's opinion was to "assume[] that ODP always applies and only briefly referred to the language of Section 154 after concluding that ODP invalidated Appellant's claims" (emphasis in brief).  The proper analysis, according to IPO, is to have "started (and ended) its analysis with the statute" and the proper result, arising from the proper analysis, would be that Cellect was entitled to the PTA because it had never filed a terminal disclaimer (i.e., it would be patentee's actions in doing so that provoked the loss of PTA).  The Federal Circuit's opinion to the contrary amounts to "a Catch-22 'gotcha,' [wherein a] patent owner may be entitled to a patent term adjustment under the statute, but according to the Federal Circuit's misinterpretation of the law, the patent term adjustment is a poison pill that can invalidate the patent in its entirety."

The brief asserts that the consequences of the Federal Circuit's decision is that "valuable patent rights will be unfairly invalidated, which in turn will reduce the incentive for future investment in critical research," the evidence for which is that over the past 8 years more than one million patents have been granted PTA.  Other consequences include "unnecessary confusion" in the lower courts, citing contrary decisions on similar fact patters, in Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., 2023 U.S. Dist. LEXIS 221663, at *21–24 (D. Del. 2023) (that ODP did not apply), and Allergan USA Inc. v. MSN Labs. Priv. Ltd., 2023 U.S. Dist. LEXIS 172641, at *59–60 (D. Del. 2023) (the latter case having been reversed in the interim by the Federal Circuit).  And this uncertainty will apply to continuation practice under § 120 and evoke "retroactive invalidation of many otherwise valid patents" IPO warns in its brief.

Sonos, Ring Central, Nagra Kudelski Group, and Capstan Therapeutics:  This collection of smaller innovation-based companies argue in their brief that it is important for patent holders to know how long the patent term will be received in exchange for disclosure of their inventions to the public.  This consideration involves both practical (need for investment decisions) and ethical (comprising the quid pro quo of the patent system) realities in their view.

The Federal Circuit's decision in the Cellect case undermines basic certainty for a wide range of inventions, this brief asserts.  Reviewing the bases for ODP development these amici argue that, absent gamesmanship it makes "very little sense" to apply ODP to today's circumstances, where all patents expire 20 years from their earliest priority date.  Here, the Federal Circuit expanded ODP to extend to additional patent term "(i) expressly provided by statute and (ii) created solely and exclusively by administrative delays within the Patent Office."

This decision and application of ODP to PTA determinations are important, these amici assert, because such administrative delays occur frequently (over 50% of patents filed after enactment of Section 154(b) have been awarded PTA, on average in excess of 6 months, relying on Mark A. Lemley & Jason Reinecke, Our More-than-Twenty-Year Patent Term 1, 14-15 (Stanford L. & Econ. Olin  Working Paper No. 586, 2023), https://ssrn.com/ab-stract=4529670 and Dennis Crouch, Prosecution Delays and Patent Term Adjustment on the Rise Again (Nov. 13, 2022), https://pa-tentlyo.com/).  In the face of such statistics, the Federal Circuit's decision mandates that "even when a challenged patent expires later than the reference patent due to the Patent Office's delay and not as the result of any tactics by the patent owner, a court must invalidate that patent if it believes an earlier-to-expire patent in the same family renders it obvious" according to amici.  This is error because it "allows a judge-made doctrine to cut short a statutory patent term mandated by Congress; contradicts Federal Circuit precedent; treats two forms of statutory term adjustments differently even though the language of the statutes are similar; and upsets equitable considerations underlying the purpose of ODP."

Amici assert that this brief is filed not to rehash these arguments but to "highlight the practical concerns the Federal Circuit's ruling creates for technology-driven companies, and the fundamental ways the ruling contradicts both basic fairness and predictability," stating that this is "not a situation where the [Supreme] Court should wait and see how the doctrine develops" (emphasis in brief) because it "impacts the investments (many of which will be years in the making) that companies like the amici are making now."

Their argument further asserts that "[p]redictability is crucial to innovation," because "[c]ompanies rely on knowing the duration of patent protection in a variety of circumstances including: (i) when making decisions about research and development budgets, (ii) when deciding how to protect their innovations (e.g., whether to apply for patents or rely on trade secret protection), and (iii) when evaluating acquisitions of other companies."  The Cellect decision has upended this predictability for at least these reasons:

First, the structure of patents and patent claiming, and how they are used to protect technologies for innovative companies, result in each individual claim protecting only "a small fraction of what has been invented."  As a result while the patent specification is a detailed description of several related inventions or aspects thereof each claim set encompasses (and protects) only a small subset of what is disclosed in the specification.  These are typically pursued in continuation applications filed according to the priority (i.e., value) of these different aspects.  These practices are sanctioned by the patent statute and do not raise concerns regarding gamesmanship (the brief saying it would be counterproductive and expensive to file all these claims in one application).  The result is filing many applications in patent portfolios for which, prior to the Cellect decision, patent holders understood their expiration dates (based on their earliest priority dates and any PTA earned during prosecution as a result of PTO delay).  This is no longer the case under Cellect, because now patent owners must determine expiration dates for each family member and the claims in each and then assess "the likelihood that a court will later find each individual claim of the later-expiring patents to be obvious relative to one or more claims of the reference [i.e., earliest-expiring] patent" (emphasis in brief) (this assessment constituting "only an educated guess" according to amici).  In addition to the legal uncertainties, this exercise poses "a gargantuan problem" in terms of number of patents and "millions in patent costs" required to be performed.  "If the Federal Circuit intended to undermine the settled expectations of patent holders, it would be hard to imagine a more effective way to do so," the brief asserts.

Second, there is a great (and negative) impact on investment decisions by innovative companies, amici argue, affecting research and development, whether to pursue patent protection or rely on trade secrets or abandon intellectual property protection entirely.  This outcome is contrary to the well-recognized importance of patent protection for supporting innovation, as evinced by the Court's decisions in Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 63, (1998); Apple Inc. v. Samsung Elecs. Co., 809 F.3d 633, 647 (Fed. Cir. 2015); Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006); and Patlex Corp. v. Mossinghoff, 758 F.2d 594, 599 (Fed. Cir.), on reh'g, 771 F.2d 480 (Fed. Cir. 1985), and indeed even the Founders' inclusion of provisions for IP protection in the Constitution.  These legal principles, amici contend, are supported by academic and other studies showing that "legal decisions that change the expected value of patents have impacts on technology investments," citing as examples Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014) (where "a survey of 475 venture capital and private equity firms reported that 62% of investors said that their firm was less likely to invest in companies developing technologies that may not be patent eligible"; David O. Taylor, Patent Eligibility and Investment, 41 Cardozo L. Rev. 2019, 2027-28 (2020), https://pa-pers.ssrn.com/sol3/papers.cfm?abstract_id=3340937) and another survey after the Supreme Court's Bilski v. Kappos, 561 U.S. 593 (2010), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), decisions that showed "investment in diagnostic technologies was nearly $9.3 billion dollars lower than it otherwise would have been"; A. Sasha Hoyt, The Impact of Uncertainty Regarding Pa-tent Eligible Subject Matter for Investment in U.S. Medical Di-agnostics Technologies, 79 Wash. & Lee L. Rev. 397, 445-46 (2022), https://scholarlycommons.law.wlu.edu/wlulr/vol79/iss1/8/).

The Cellect decision not only reduces patent protection value but also makes protection "less predictable" (emphasis in brief), under circumstances where the amount of PTA to which a patentee is entitled depends on "unknown and stochastic processes within the Patent Office."  As a consequence, amici argue, the traditional exchange of patent protection for disclosure to the public becomes "something of a lottery" (emphasis in brief).  And these are the circumstances that arise if innovative companies continue to pursue patenting; amici contend that the reduction of return on (the quite large) investment in patenting "materially undermines the incentive to apply for patents in the first place" which "represents a serious loss to the public in the long term."

Sanofi, Beigene, Merck Sharp & Dohme, EMD Serono, and Pfizer:  This brief provides an extensive history of the development of ODP (also termed herein "non-statutory double patenting" or "NSDP") and also that certainty and predictability has been disrupted by the Federal Circuit's Cellect decision.  The brief emphasizes the legal history of ODP and how it has become outdated inter alia by adoption of the 20-year patent term for U.S. patents, as well as the equitable aspects arising before adoption of the URAA/TRIPS regime, as a judicially created doctrine preventing serial filing and issuance of obvious variants of an invention.

The brief asserts that despite elimination of the opportunity for "gamesmanship" in patent term under U.S. law after adoption of the URAA/TRIPS regime the Federal Circuit in Cellect "expands [the scope of] NSDP anyway," according to amici, citing In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013), and Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217 (Fed. Cir. 2014).  Cellect in another example, here on the novel question of "whether NSDP could invalidate claims of patents within a family solely because of a statutory grant of PTA to some members of that family" (the answer being yes, of course).  In addition, amici argue that the decision has "sow[n] confusion in district courts, citing the poster-children for this confusion, Allergan USA, Inc. v. MSN Lab'ys Priv. Ltd., 2023 WL 6295496 (D. Del. Sept. 27, 2023), and Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., 2023 WL 8803448 (D. Del. Dec. 13, 2023).

Amici argue that this history establishes that the Cellect decision is "destabilizing" to the patent regime, particularly for the pharmaceutical industry, in part due to the "enormous" cost of investment in the face of patent term that is no longer "definite and predictable" being subject to "administrative inefficiencies and judicial whim."  The decision not only undermines the equitable principles upon which the ODP doctrine was established but is also legally incorrect based on proper construction of § 154(b)(2)(B) of the statute, these amici argue.  "The Federal Circuit applied a judge-made equitable doctrine in an inequitable way, contravening Congress's statutory guarantees in the process," the brief summarizes.  The brief also supports the value of patents (and the need for predictability thereof) in the pharmaceutical and other industries with numerous academic legal and other studies attesting to the public benefit of this investment.  The brief further addresses the "balance" between lowering drug prices and encouraging (through profit) investment to develop new drugs ("a policy question for Congress—not courts—and Congress has addressed that policy question many times," citing examples such as the Hatch-Waxman Act).

In addition to these policy and practical errors, the brief expounds on the legal errors committed by the Federal Circuit, including misconstruing § 154(b)(2)(B).  These number three: first, contrary to the panel's rationale, "terminal disclaimers are not tied to NSDP the way the Federal Circuit presumed" (i.e., that filing a terminal disclaimer was always associated with NSDP).  Second, while NSDP was crafted (and § 154(b)(2)(B) enacted) for circumstances involving "serially filed applications with different default patent terms" (emphasis in brief) the Federal Circuit applied the doctrine to patents within the same patent family sharing a common default patent term (i.e., 20 years from a common earliest priority date).  Properly understood, amici argue that § 154(b)(2)(B) was intended to apply to situations where "original patent applications containing patentably indistinct claims are filed separately on different dates, rather than as part of the same patent family, resulting in patents with different default terms," [wherein] "NSDP might apply to the later-filed, later-expiring patent because the patents would have different default patent terms—different start and end dates—which is controlled by the patentee."  (And to the extent Congress wanted the Federal Circuit's interpretation to apply, the brief argues it would have said so expressly.)

Amici also contend that applying NSDP in this situation is a misapplication of a doctrine intended to police unjustified extension of patent term to patent term extensions justified by a grant expressly enacted by Congress.  "Statutory guarantees like PTA are not unjustified, nor are they even in the patentee's control," the brief asserts, providing two reasons why applying NSDP as the Federal Circuit did in this case was error.  Finally in this regard amici argue that applying NSDP to situations not involving gamesmanship or other culpable behavior is a misapplication of the equitable principles underpinning NSDP.

The brief concludes with an exhortation of the importance for the Court to grant certiorari, inter alia, to address the Federal Circuit's replacement of "Congress's carefully calibrated patent regime with one of judicial design" specifically with regard to pharmaceutical innovation including the costs thereof and the accompanying need for predictability for this technology.

Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO):  The principle argument in this brief is that the Federal Circuit used judicially created doctrine to overrule statutory PTA, while secondarily the brief argues that the decision upsets settled expectations.  Amici's stated interests are "[t]o protect [their] investments, members of PhRMA and BIO depend on a patent system that is robust, fair, and predictable. In particular, amici rely on the patent system to protect the diverse array of innovations they make in connection with developing a new medicine or treatment, including the unique compositions required to safely and effectively use new medicines in patients and novel manufacturing technologies needed to safely produce amounts of those medicines sufficient to meet an often immense patient demand."

Amici argue that the nature of these technologies requires "filing a series of related patent applications derived from an original filing based on the inventive work."  As a consequence, they obtain patents with various expiration dates that are "dictated by the statutory scheme at issue here," wherein those terms vary according to the PTO "failing to meet its statutory deadlines in conducting the examination of the associated application."

The brief contains these graphics to illustrate the effects on patent term created by the U.S. adopting the URAA/TRIPS regime that changed the term of U.S. patents from 17 years from issue to 20 years from earliest priority date:

The prejudice illustrated in this graphic motivated Congress to enact 35 U.S.C. § 154(b) to restore term lost due to PTO delay:

With specific instances of how the regime responds illustrated in this figure:

The brief asserts that this "judge-made doctrine of non-statutory double patenting cannot displace these statutory requirements for patent-term adjustments" which is "clear from the statutory text of 35 U.S.C. § 154(b)."  (The brief also notes that the equitable basis for ODP was largely eliminated by the changes in term occasioned by adopting the URAA/TRIP regime.)

The patent term adjustment regime according to the brief is "an essential part of the PTO's application-by-application examination process," consisting of a "back-and-forth dialogue between the PTO and the inventor."  In order to adequately protect innovation in these disciplines, "[l]ife sciences innovators commonly file robust applications reflecting the broad array of innovations that come with developing a new medicine," which include "not only the most promising active ingredient discovered but other promising candidates as well."  The result is that innovators can obtain "patent rights that provide commercially viable protection" that, in addition to preventing competitors from avoiding their patents by making simply narrow changes also benefits the public due to publication that occurs whether or not a patent is ever obtained.  But such patent applications take time to secure and often involve several rounds of continuation applications to pursue some claims not included in a patent arising from the first application filed but nevertheless ultimately deemed patentable (the brief explicating the history of such applications and the benefits that arise therefrom).

The brief further sets out their argument that judge-made law cannot negate the statutory mandate, citing the differences between Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (regarding PTA under § 154(b)) and Novartis AG v. Ezra Ventures LLC, (regarding PTE under § 156(a)).  Also argued are amici's contentions that the Federal Circuit misinterpreted the statutory language, which was related to instances where a terminal disclaimer had been filed, not ones where a court determines it should have been (and in a footnote echoes other amici that the Federal Circuit erred in considering ODP as the exclusive reason for filing a terminal disclaimer).

With regard to settled expectations, the brief emphasizes the risk to innovative industries due to the time and expense of bringing pharmaceutical and biotechnology products to market and the related need for reliable patent protection with predictable term to ensure a chance at sufficient return to justify investment.  The brief says that the Federal Circuit's error relates to all technologies, citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002), but particularly affects innovation for pharmaceutical and biotechnology inventions (supported by several academic and industry studies) due to the excessive costs and time it takes to bring products to market in these industries and the propensity for failure.

Finally, the brief reminds the Court that they have "often granted certiorari to realign the Federal Circuit's doctrines with governing statutes," naming SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018); Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016); and Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (frankly the brief could have named several more but the point was undoubtedly made).

Teige P. Sheehan:  Teige P. Sheehan, a patent attorney, filed an amicus brief on his own behalf and argued specifically that the Federal Circuit's reasoning was circular and that the statute requires ODP to be resolved before PTA is assessed.  Regarding the circularity argument, the brief contends that a terminal disclaimer is a "cure" for an ODP defect by truncating the patent term to an earlier expiration date and that § 154(b)(2)(B) states that a PTA award cannot extend the expiration date later than the date set by the terminal disclaimer.  The Federal Circuit held that "because § 154 states that a terminal disclaimer—the cure for ODP—limits a PTA award, a PTA award itself can confer unpatentability for ODP in the absence of a terminal disclaimer" (emphasis in brief). Mr. Sheehan asserts in his brief that "[t]his is a classic instance of circular reasoning, an illogical basis for analysis repeatedly dismissed by this Court (e.g., in Nationwide Mut. Ins. Co. v. Darden, 503 U.S. 318, 327 (1992); King v. St. Vincent's Hosp., 502 U.S. 215, 222 (1991); Morse v. Republican Party of Virginia, 517 U.S. 186, 233 n.43 (1991); and Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984)) and which "provides no insight at all into whether Congress intended for a PTA award to confer ODP invalidity."  "[T]he statute explains the consequence on PTA of a terminal disclaimer having been entered to overcome ODP," the brief argues, [but] "[i]t does not mean, as the Federal Circuit would have it, [that] PTA creates the need for the terminal disclaimer by causing ODP invalidity."  And as with other amici (and Cellect itself) the brief also argues that this application of ODP doctrine by the Federal Circuit thwarts Congress's scheme for restoring patent term due to PTO delays under § 154(b).

The statute asserts that the proper application of the statute, consistent with Congressional intent, is for ODP issues to be resolved before application of any PTA is awarded.  Such an application of the law would avoid instances that cause their own, unique anomalies, such as where "a patent can validly issue with a PTA award and its corresponding expiration date publicized, only to be rendered invalid for ODP later, when another patent subsequently issues."  This is exactly what occurred for two patents at issue in Cellect: "U.S. Patent No. 6,424,369 ("the '369 Patent") issued with an award of 45 days of PTA.  Over two-and-a-half years later, another patent was issued to Petitioner, U.S. Patent No. U.S. 6,862,036 ("the '036 Patent"), without receiving a PTA award.  . . .  The '369 Patent's 45 days of PTA meant it was set to expire after the '036 Patent did, resulting in a supposedly unjust extension of patent term, according to Respondent [and the Federal Circuit]."

The brief concludes that "[t]his inflexible application of ODP is not only contrary to Congress's intent that ODP should be determined based on a patent's expiration date absent PTA, as expressed in § 154, but also serves none of the purported purposes of ODP doctrine while delivering an inequitable result to a patentee."

Amicus for Respondent:

Inari Agriculture, Inc.:  The only amicus brief submitted in support for Respondent was filed by Inari Agriculture, Inc. and this brief takes a decidedly aggressive and aggrieved tone in favor of the Federal Circuit's decision and the rationales behind it.  The company describes itself as being formed to "develop pioneering technology to selectively edit plant genes to enhance agronomic traits to increase crop yields and decrease inputs such as water and fertilizer," that "partners with independent seed companies to develop improved seeds using Inari's technology" but for whom ODP is needed to "protect[] innovators­ like Inari-from earlier patentees seeking to leverage legacy technology after their patents expire."  It castigates "an oligopoly of entrenched incumbents" that "dominate seed distribution and suppress competition" by abusing the patent system, spurred on by "commentaries [that] highlighted brazen strategies for exploiting loopholes in the PTA system [citing blog posts directed to maximizing PTA-increased term] and delaying patent issuance while wrongly attributing such delays to the PTO."  Examples cited in the brief include "[t]wo companies-Corteva and Bayer/Monsanto­[that] control over 70% of the U.S. corn seed market and 85% of corn-related intellectual property" and that "[t]ogether with BASF and ChemChina's Syngenta Group, these oligopolists own 95% of corn-related IP," by exerting patent rights over genetically modified seed.  The brief also cites extensively from briefs and other assertions by the Federal Trade Commission regarding such putative abuses, which the brief contends will (and in some instances at least prospectively already have begun to) address these issues (albeit a large portion of the brief also seems to set forth Inari's own arguments against these companies rather than address the question of certiorari grant, except to the extent that by doing so the Court might take away a tool that Inari believes will aid it in competing with the "oligarchs.")

One final consideration remains (not addressed in these briefs because it arose after they were filed), which is the Federal Circuit's recent decision in Allergan USA Inc. v. MSN Laboratories Private Ltd.  In that case, a panel made up of the same Federal Circuit judges that decided In re Cellect reversed a district court decision that putatively applied the Cellect calculus for assessing when PTA can invalidate claims under the ODP doctrine.  The relationship between the patents at issue in Allergan was as follows:

In this case, the district court held that the '356 patent was invalid on obviousness-type double patenting grounds (ODP) for having patentably non-distinct claims over the '011 and '709 patents.  The district court expressly relied on the Federal Circuit's Gilead Scis., Inc. v. Natco Pharma Ltd. and In re Cellect decisions in reaching this judgment.  Nevertheless, the Federal Circuit reversed.  The rationale behind this (seemingly contrary) decision was that "Cellect established a rule that, when it comes to evaluating ODP on a patent that has received PTA, the relevant expiration date is the expiration date including PTA—not the original expiration date measured twenty years from the priority date."  That was not the factual posture in Allergan, according to the Court, which asserted the following rule for determining the effects of OPD on PTA:  "a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date"; as applied here the district court erred "[b]ecause the '356 patent was the first patent in its family to be filed and to issue, it [thus] does not extend any period of exclusivity on the claimed subject matter."  A comparison of the timelines in Allergan and Cellect reveals that these decisions are not completely consistent.  The existence of the decision, however, might be enough to convince the Supreme Court that it would be more prudent not to grant Cellect's certiorari petition and to permit the Federal Circuit to resolve a consistent application of ODP and PTA law before the Justices wade into these murky waters themselves. We should know how the Court decides by tomorrow.

In re Cellect in View of Supreme Court's "Long Conference"

By Kevin E. Noonan --

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision.  While that Court's recent Allergan USA Inc. v. MSN Laboratories Private Ltd. opinion may have made the issues (and whether the Supreme Court grants cert) less urgent, the pending U.S. Patent and Trademark Office (PTO) proposed rules limiting terminal disclaimer practice for overcoming obviousness-type double patenting and the permissible scope of those rules by an administrative agency after Loper-Bright Enterprises v. Raimondo continue to garner interest regarding whether the Court will take up review of this decision.

To recap, the issue arose in a series of ex parte reexaminations over five patents owned by Cellect, U.S. Patent Nos. 6,424,369; 6,452,626; 6,982,742; and 7,002,621, that involve "solid state image sensors which are configured to be of a minimum size and used within communication devices specifically including video telephones" according to the '621 patent (only four of these patents were invalidated, the fifth, U.S. Patent No. 6,862,036 not having any PTA that raised the issue).  The chronological situation is set forth in an exhibit from Cellect's Federal Circuit appeal brief and reproduced in modified form in the opinion:

The Federal Circuit affirmed the Patent Trial and Appeal Board decision invalidating the four patents that had term extending longer than that of the earliest to expire patent, U.S. Patent No. 6,862,036, which had amassed no patent term adjustment under 35 U.S.C. § 154(b) based on the provision of subsection 35 U.S.C. § 154(b)(2)(B) that stated:

No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer . . . .

According to the Federal Circuit, it is inequitable to the public that a second, later-expiring patent should be obtained ("an unjustified timewise extension of patent term") on an obvious variant of a patented invention, based on AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1373 (Fed. Cir. 2014) (there was no dispute that the claims in these five patents were not patentably distinct).  The panel's opinion found support in the statute (as had the Board), wherein application of PTA was limited under circumstances where there was or should have been a terminal disclaimer filed under 35 U.S.C. § 154(b)(2)(B); the fact that no such terminal disclaimer(s) were filed were not relevant to the Court's decision that the principle applied because they should have been filed.  The Court's decision was supported by the overriding policy consideration that the Court focuses on the need to "ensure that the applicant does not receive an unjust timewise extension of patent term" (as it has for over a decade; see "In re Janssen Biotech, Inc.; G.D. Searle LLC v. Lupin Pharmaceuticals, Inc."; "AbbVie Inc."; "Gilead Sciences, Inc. v. Natco Pharma Ltd."; "Eli Lilly & Co. v. Teva Parenteral Medicines, Inc."; and "Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.").  In so ruling, the Federal Circuit dismissed patentee's argument that patent term adjustment should not be treated any differently from patent term extension (PTE), for which the Court ruled in Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018) that a statutorily mandated extension of term should not be lost under a judicially created doctrine.  The reasoning by the Court was that the statutes were independently enacted and had "quite different purposes."

Cellect's cert petition asserts error in the Federal Circuit's decision on grounds set forth in the Question Presented:

Whether a patent procured in good faith can be invalidated on the ground that statutory Patent Term Adjustment, which requires lengthening a patent's term to account for time lost to Patent and Trademark Office delays, can trigger a judge-made patent-invalidation doctrine.

In support of this Question, the Petition asserts that "the Federal Circuit has substituted a judge-made equitable doctrine for a patent term guaranteed by Congress."  In arguments in support of the Petition, Cellect asserts that the only reason for the different expiration dates of these patents is that "the Patent Office did not comply with its statutory deadlines for acting on patent applications," which raised patent term adjustment under the statute, with there being no evidence or allegations of gamesmanship, bad faith, or improper actions by patentee.  Cellect's arguments contrast the Federal Circuit's treatment of the statute under this case and Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1375 (2018), analogizes the PTA statute with how Congress enacted the earlier PTE statute, and asserts as evidence of Congressional intent to harmonize the two statutes the inclusion of the phrase "which shall include any patent term adjustment granted under section 154(b)" to § 156(a) when § 154(b) was enacted.  The PTE (§ 156a) and PTA (§ 154b) statutes "serve the same purpose," the brief contends, restoring patent term lost by bureaucratic delay (by FDA and PTO, respectively), and both use the mandatory phrase that lost term "shall be extended" for the appropriate period.

The brief contains a very simplified example to illustrate how PTA is applied (although the wisdom of making it too simple may be questioned):

By way of illustration, ODP applies when the owner of a patent for sliced bread goes on to seek related patents for sliced white bread and sliced wheat bread, and prosecutes those patent applications strategically so that they expire after the original patent and enlarge, in effect, the original patent's term through patenting obvious or marginal variations of its claims.

As to reasons for granting the petition, the brief asserts that the Federal Circuit "turned a congressional 'guarantee' of a minimum effective patent term on its head by converting that guarantee into a threat to the validity or term of countless continuation patents."  Additional reasons supporting cert grant are that this change is "extremely consequential" to patentees, the issue here is plainly presented (should a judge-made doctrine supersede "an express statutory grant"?), and the Supreme Court is the only resort against the Federal Circuit, the brief stating that "the Federal Circuit's word on the question will be the last one in all patent cases unless this Court grants review."

Specific aspects of Cellect's arguments include that the plain text of the statute ("shall be extended") "forecloses" the Federal Circuit's opinion under Supreme Court precedent, including Jennings v. Rodriguez, 583 U.S. 281, 300 (2018) (quoting Kingdomware Techs., Inc. v. United States, 579 U.S. 162, 171 (2016)); that courts are prohibited from adding exceptions to a statute not included by Congress, citing Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980) (quoting United States v. Dubilier Condenser Corp., 289 U.S. 178, 199 (1933)); that the decision is contrary to Supreme Court decisions on consistency when statutes used same language, "serve the same purpose" and are "analogous," Abbott v. Perez, 585 U.S. 579 (2018); criticizes the Federal Circuit's reasoning regarding the language in § 154(b) suggesting a role for terminal disclaimers where such language was not found in § 156(a); is inconsistent with the Federal Circuit's decision in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., 909 F.3d 1355, 1366 (Fed. Cir. 2018); and that "[i]n spurning the traditional, equitable ODP inquiry in favor of rigid presumptions of its own invention, the Federal Circuit repeated an error that this Court has often granted certiorari to correct," citing eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 393 (2006); Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139, 157 (2010); Nken v. Holder, 556 U.S. 418, 435, 436 (2009); Munaf v. Geren, 553 U.S. 674, 690 (2008); New York Times Co. v. Tasini, 533 U.S. 483, 505 (2001); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).

As to the importance of the question, the brief asserts that the Federal Circuit's decision "upsets investment-backed expectations" contrary to Supreme Court admonitions in, for example, Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002); that it generates uncertainty, harming investment decisions, and "radically undermines . . . predictability"; and that it cause confusion in the lower courts, comparing district court decisions in Allergan USA, Inc. v. MSN Labs. Priv. Ltd., No. Civ. A. 19-1727-RGA, 2023 WL 6295496, at *22 (D. Del. Sept. 27, 2023) (since reversed by the Federal Circuit) with Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., No. Civ. A. 20-985-GBW, 2023 WL 8803448, at *8 (D. Del. Dec. 13, 2023).  The brief also notes the importance for "long-lead-time, high-investment industries like pharmaceuticals," using PTE as an example (keeping in mind that the technology here does not have these attributes); is "especially burdensome" on smaller businesses; "upends well-established patent practice"; and predicts that inventors "will be compelled to prepare larger, all-but-the-kitchen-sink applications right out of the gate, thus delaying the arrival of important innovations and then swamping the Patent Office with administrative difficulty."  Consequently, the decision raises the potential for "invalidation of hundreds of patents worth billions or trillions of dollars" due to "retroactive invalidation" under circumstances where "these are problems of the Patent Office's own making" because "[a]s long as the Patent Office acts on applications within the statutory deadlines, there is no PTA in the first place"

Finally, the brief characterizes this case as an ideal vehicle for the Court to decide, because there are no underlying issues of fact, no challenge that the claims were not patentably distinct, and that the Court can reach these issues for both PTE and PTA.

The government's response in opposition has the tone of "move along, nothing to see here" regarding Cellect's assertions in their Petition.  The government's contrasting Question Presented to the Court is:

Whether the ban on obviousness-type double patenting applies when patent-term adjustment causes a challenged patent to remain in force after the reference patent expires.

The brief dismisses Cellect's reliance on Section 156 as being a different part of the statute enacted for a different purpose and sees no contradiction with Section 156 because Section 154 contains express provisions regarding terminal disclaimers and Section 156 does not.  According to the government, the statutory entitlement for PTA is bounded by exceptions including the one for patents having restricted term, and these differences evince a distinction Congress made between Sections 154 and 156 that justify the Federal Circuit treating them differently here and in Novartis v. Ezra Ventures.

The brief raises an historical prohibition against double patenting relying on Miller v. Eagle Mfg. Co., 151 U.S. 186, 197 (1894), and Odiorne v. Amesbury Nail Factory, 18 F. Cas. 578, 579 (C.C.D. Mass. 1819) (No. 10,430) (Story, J.), that mandate that it is the later patent that "must be declared void," with Section 101 of the 1952 Patent Act as codifying this prohibition and Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014), as extending this prohibition to "obvious modifications of that invention that are not patentably distinct improvements," now termed obviousness-type double patenting, citing Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001), cert. denied, 534 U.S. 1109 (2002).  The ready remedy is filing a terminal disclaimer under Section 253(b) according to their brief, citing Application of Robeson, 331 F.2d 610, 614 n.4 (C.C.P.A. 1964).

The government urges the Court to recognize that the current situation arose, in part, due to changes in the Patent Act caused by adoption of the Uruguay Round Amendments, and the government sees the current situation as being how it has handled the likelihood that certain patentees would lose term due to PTO delay.  Similarly, the brief discusses the origins and policy rationales for Section 156 and by contrasting them hopes to distinguish them.  The brief asserts that the Federal Circuit took into consideration the plain meaning of the statute in reaching its decision and that the absence of any evidence of gamesmanship by patentee did not change the analysis.

In an instance where a Federal Circuit-derived "bright line rule" may be justified and helpful for achieving consistency, the brief argues that "the statutory recognition of the binding power of terminal disclaimers in § 154(b)(2)(B) is tantamount to a statutory acknowledgement that [obviousness-type double patenting] concerns can arise when PTA results in a later-expiring claim that is patentably indistinct" and "when a terminal disclaimer has been entered in a patent subject to PTA, no patent (or claim) may be extended beyond the disclaimed expiration date."  The Federal Circuit properly recognized that ODP and terminal disclaimers were "two sides of the same coin" and thus was justified in its interpretation of § 154(b)(2)(B) according to the government.  The government's brief attempts to blunt Cellect's argument that the Federal Circuit used the judge-made doctrine of ODP to overcome the provisions of the statute by saying that "while sometimes 'described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act,'" citing Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1372 (Fed. Cir. 2014), and Miller v. Eagle Mfg. Co., 151 U.S. 186, 197 (1894), Parker Drilling Mgmt. Servs., Ltd. v. Newton, 587 U.S. 601, 611 (2019), and AbbVie.

With regard to the differences in treatment by the Federal Circuit between Section 154 and Section 156, the brief states that a critical textual distinction between Section 154 and Section 156 shows that Congress intended the two schemes to operate differently.  Whereas Section 154 precludes the use of PTA to extend a patent's expiration date beyond the "date specified in [a terminal] disclaimer," 35 U.S.C.154(b)(2)(B), Section 156 contains no comparable carveout and the Federal Circuit "recognized that distinction" in Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (2018) (which decision also recognized this distinction regarding Section 154).

The brief also asserts that the fact that it is undisputed that the claims in the different Cellect patents at issue were obvious variants of each other trumps the equity argument because undisputably these claims were in force after their proper expiration date and equity demands that they be invalidated under these circumstances, citing Boehringer Ingelheim Int'l GMBH v. Barr Labs., Inc., 592 F.3d 1340, 1348 (Fed. Cir. 2010).  The brief also argues that there is also no requirement for gamesmanship nor fraud for Section 154 to be applied here, based on the need to protect the public from unjustified extension of the patent term.

Regarding Cellect's assertions on the importance of this case for Supreme Court review, the government argues that the Question Presented by petitioners is "not sufficiently important to warrant this Court's intervention" because it was consistent with earlier Federal Circuit precedent, was a unanimous decision and was not subject to rehearing.  Petitioner Cellect's argument that no other circuit will be able to consider the question is not germane because there hasn't been any disagreement among the Federal Circuit indicating a need for further review.  The Question Presented by petitioners is "not sufficiently important to warrant this Court's intervention" because it also "lacks substantial practical importance" due to limited applicability, i.e., when "a patent owner obtains a later-expiring patent that has claims that are not patentably distinct from those of an earlier-expiring patent; the USPTO's delay in examining and processing the later patent is sufficient to trigger PTA; the USPTO examiner does not recognize the indistinct nature of the claims of the later patent and does not reject them based on double patenting; and the patent owner does not follow the usual practice of filing a terminal disclaimer with respect to the later-expiring patent."  And any frustrated expectations by investors are not justified under the "bedrock principle" against double patenting (i.e., their expectations are not justified in the first place, particularly in view of "Section 154(b)(2)(B)'s express carve-out of terminal disclaimers from that grant [of PTA]").

The brief also mentions the Federal Circuit's decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024), as removing any inconsistencies in the Court's jurisprudence.  The government's brief dismisses Petitioner's assertions that patentees will be newly burdened with the need to review all claims in related patents (which exists now) and disruptions in continuation practice based on Allergan.

Cellect Reply Brief

Cellect, in its Reply brief, addresses some "misstatements" made by the government (such as that "the rule against obviousness-type double patenting (ODP) is statutory rather than judge-made") and the government's arguments.  The first of these is displacement by the PTA statute which Cellect asserts it did not advance and, perhaps more importantly is actually about ODP displacing PTA rather than (as the government asserts according to Cellect) the other way around.  Cellect characterizes this argument as an admission by the government that the Federal Circuit's opinion is "indefensible."  Cellect challenges the government for trying to avoid the reality that the Federal Circuit performed a "massive and consequential rewrite of the statute."  And the Reply brief reiterates Cellect's contention that it is inexplicable (or at least the government has not provided an explanation) of why the Federal Circuit treated the application of ODP for PTE differently than PTA.

The argument focuses on the Federal Circuit's construction of the portion of the statute that specifically mentions terminal disclaimers and criticizes for being counterintuitive the government's position regarding situations (like the one at issue) where terminal disclaimers have not been filed and the effect on PTA.  The government's reading amounts to a "back door limitation" to the statutory guarantee of PTA extension of patent term according to the Reply brief which is "especially implausible because the proffered limitation case (as it did [in this case]) wholly invalidate a patent that has no terminal disclaimer" (emphasis in brief) (the brief characterizes such actions by Congress if intentional to be nothing less than "cagey," citing Whitman v. Am. Trucking Assoc. for the principle that Congress "does not hide elephants in mouseholes").  The brief uses an analogy from immigration law to illustrate the incongruity Petitioner believes the government's (and Federal Circuit's) statutory construction produces.  The best and most consistent answer Cellect proffers is that "the [statutory] text limits PTA only when a terminal disclaimer has been filed and states that 'PTA shall be granted' when no terminal disclaimer is filed" (albeit avoiding the issue of the proper determination in cases like this where a terminal disclaimer should have been filed).

The brief also provides its rebuttal to the government's position on the disparity between how ODP is applied to awarding term extensions for PTA and PTE; the effects of the changes in U.S. patent term by adoption of the URAA/TRIPS regime; and the equitable foundation of ODP.

Regarding the importance of the Question Presented and whether the Court should grant certiorari, the brief reiterates its arguments (and criticizes the government's attempts to "minimize the importance" by "protestations [that] ring hollow" and "fail to grapple" with experiences contrary to their arguments by better-informed amici.  And the brief characterizes the recent Federal Circuit decision in Allergan v. MSN to be an "ad hoc turnabout" as being "the wages of ignoring the statutory text."

The amicus briefs that were filed on behalf of Petitioner and Respondent will be the subject of a subsequent post.

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and Trademark Office under a substantial evidence standard.  The consequences of this standard are illustrated (once again) in the Federal Circuit affirming the Office's determination in an inter partes review (IPR) proceeding invalidating the challenged claims, in Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.

Challenger Regeneron obtained institution of the IPR for all claims on U.S. Patent No. 9,220,631 owned by Novartis.  The claims were directed to "a small volume syringe such as a syringe suitable for ophthalmic injections."  Such syringes are useful for administering therapeutic agents (such as vascular endothelial growth factor (VEGF) antagonists) to the eye for treating ocular diseases.  Suitable syringes must be sterile and in order to avoid damaging the therapeutic agent must be sealed to prevent sterilizing agents (such as hydrogen peroxide) from contaminating the drug.  Tight seals have the disadvantage of increasing the pressure (force, termed according to the opinion the "break-loose force") required to administer the drug into the delicate ocular tissues.  A solution known in the prior art, treating the syringe with silicone oil, had the drawback that it can cause medical complications should it get into the patient's eye.

The invention claimed in the '631 patent provided the following solution illustrated by claims 1 and 21:

1.  A pre-filled, terminally sterilized syringe for intravitreal injection, the syringe comprising a glass body forming a barrel, a stopper and a plunger and
    containing an ophthalmic solution which comprises a VEGF-antagonist, wherein:
        (a) the syringe has a nominal maximum fill volume of between about 0.5 ml and about 1 ml,
        (b) the syringe barrel comprises from about 1 μg to 100 μg silicone oil,
        (c) the VEGF antagonist solution comprises no more than 2 particles >50 μm in diameter per ml and wherein the syringe has a stopper break-loose force of less than about 11N.

21.  A blister pack comprising a pre-filled syringe according to claim 17, wherein the syringe has been sterili[z]ed using EtO or H₂O₂ with a Sterility Assurance Level of at least 10^–6.

According to the Federal Circuit's opinion, Novartis did not "meaningfully dispute" Regeneron's assertions that that the prior art disclosed all the limitations recited in the challenged claims, in particular PCT Publication No. WO 2011/006877 ("Siggs") that disclosed "a pre-filled terminally sterilized syringe containing a VEGF-antagonist" and PCT Publication No. WO 2009/030976 ("Boulange") that disclosed "a stopper with the claimed silicone oil and break-loose force limitations."  Rather, it was Novartis's contention that the worker of ordinary skill in the art would not have been motivated to combine these references having a reasonable expectation of success in doing so.  Novartis also asserted that objective indicia of non-obviousness supported its claims in defense of Regeneron's challenge.

The Patent Trial and Appeal Board (Board) agreed with Regeneron in an extensive (128 page!) Final Written Decision that the challenged claims were obvious, supporting this determination by prior art references that include the Sigg and Boulange references.  The Board found that Sigg provided a terminally sterilized pre-filled syringe and that Boulange taught silicone sterilization methods that would minimize the risk of contamination.  Additionally, the Board found that the skilled worker would have had a reasonable expectation of success using the choice of stopper (Stopper C) taught by Boulange, which provided a tight enough seal to permit the syringe to be sterilized while having a break-loose force within the claimed 11N limit.  Regarding Novartis's assertion of objective indicia of non-obviousness, the Board opined that "[t]he stronger evidence of obviousness cannot be overcome with the weaker evidence of long-felt need and failure of others."

The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Prost and Reyna.  From the thirteen (!) arguments raised by Novartis, the opinion states that it considered only Novartis's principal ones.  The first of these was that the prior art teaches away from the combination of the Sigg and Boulange references.  In assessing and rejecting this argument, the Court noted that "teaching away" raised a question of fact, citing In re Fulton, 391 F.3d 1195, 1199–200 (Fed. Cir. 2004), and that the Board's factual determinations were reviewed by the Federal Circuit for substantial evidence, citing PersonalWeb Techs., LLC v. Apple, Inc., 917 F.3d 1376, 1381 (Fed. Cir. 2019).  The opinion summarized the Board's analysis as consisting of finding "a motivation to combine Sigg's sterilization process with Boulange's Stopper C because Boulange's baked-on siliconization process 'would help reduce the amount of "residual" or "free" silicone oil that can enter the protein formulation and cause negative effects'" and reviewed each in turn.  Regarding Boulange's Stopper C teachings, the panel rejected Novartis's contention that because the break-loose force of this stopper increased from 4.7N to 8.4N over three months, the skilled worker would not have chosen it in favor of stoppers with more consistent break-loose force characteristics over time.  The opinion notes that the challenged claims do not recite a limitation regarding consistent break-loose force and that the written description of the '631 patent disclosed that prior art stoppers having break-loose forces of up to 20N were "known in the prior art to be acceptable for intravitreal injections."  The Board's conclusions in this regard were also supported by the testimony of Regeneron's expert, and Novartis "did not submit any evidence showing that a skilled artisan would have been dissuaded from using a syringe that has a roughly 4N increase in break-loose force over time."  The Board's determination concerning the combination of Sigg with Stopper C as taught by Boulange was supported by substantial evidence according to the opinion.

Novartis also argued that Stopper C was "markedly inferior" to another stopper (B1) disclosed in the Boulange reference.  The panel rejected this argument on the basis that "[i]n assessing whether prior art teaches away, that 'better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes,'" the opinion citing Bayer Pharma AG v. Watson Lab'ys, Inc., 874 F.3d 1316, 1327 (Fed. Cir. 2017) (quoting In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012)).  Once again, the Board relied on Regeneron's expert, who testified that "a skilled artisan would have been motivated to use Stopper C because it was comprised of rubber and coated with silicone oil—a common stopper design in the prior art," as well as the break-loose force of Stopper C being within the claimed 11N and the 20N limits disclosed in the '631 specification.

The last argument from Novartis regarding "teaching away" was that Stopper C's "friction forces . . . were relatively high, something which does not appear to be acceptable for a medical device."  However, the data from the Boulange reference regarding such friction forces were obtained using versions of Stopper C that were not siliconized, whereas the embodiments of Stopper C relied upon by Regeneron in making its obviousness assertions in the IPR were siliconized.  It is this embodiment of Stopper C that the skilled worker would consider using, according to the Board (and this opinion), and for these embodiment the Court held that the Board's obviousness determination was supported by substantial evidence.

Novartis's second argument was that the Board erred in finding that the skilled worker would have had a reasonable expectation of success in combining the Sigg and Boulange references to achieve the claimed invention, a question also reviewed under the substantial evidence standard under, inter alia, Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016).  The basis for the Board's decision in this regard was that "Boulange's Stopper C was sealed tightly enough to be terminally sterilized using Sigg's vaporized hydrogen peroxide sterilization process," which Novartis argued was error because "Boulange's syringes were not sufficiently gas-tight to be able to use Sigg's sterilization process."  The Court considered Novartis's argument to be flawed as being "premised on an incorrect view of the [meaning] of the claim term 'terminally sterilized.'"  This is because the Board's meaning of the term was that it required "only minimizing the contact between the drug product and the sterilizing agent" (emphasis in opinion) and Novartis had not challenged that construction on appeal.  Thus, statements in the Sigg reference that few products had the "required tightness . . . to avoid ingress of sterilizing gasses [into the prefilled drug containing syringe]' (emphasis added) did not deprive the Board of substantial evidence regarding the skilled worker's reasonable expectation of success.  Yet again, the Board relied on Regeneron's expert testimony that "it was standard to design prefilled syringes to be gas-tight to protect the drug from degrading over its shelf life and to prevent sterilizing gas from entering the syringe," which was consistent with the Boulange reference, which disclosed that "lower break-loose forces are achievable in the invention 'without having to add lubricant and while preserving the tightness of the contact region between said two parts'" (emphasis in opinion).  In addition, the opinion notes that there was no evidence asserted that "any special tightness or specific stopper material, coating, or dimensions[] would have been required to achieve terminal sterilization."

A final Novartis argument addressed by the Court  in the opinion was the Board's determination that the Sigg reference disclosed the limitation in claim 21 of a sterility assurance level of at least 10^–6 being achieved using vaporized hydrogen peroxide.  The panel found the Board's conclusion in this regard to be supported by substantial evidence based on statements in the Sigg reference that "sterility for a health care product as achieving a sterility assurance level of 10^–6" combined with a description of vaporized hydrogen peroxide as being a "sterilization treatment."  The Board combined these teachings from the prior art with expert testimony from Regeneron to conclude that "a skilled artisan would have known a sterility assurance level of 10^–6 was based on regulatory requirements for health care products, and therefore pre-filled syringes are required to meet that sterility assurance level," which, according to the opinion, was supported by substantial evidence.  Although (for this issue) the Court implicitly acknowledged Novartis's identification of an inconsistency in some of Regeneron's evidence, the Federal Circuit held that under the substantial evidence standard "one inconsistent piece of evidence does not undermine [the Board's] finding."

In a footnote, the opinion addressed two other arguments made by Novartis.  First, the Court held that the Board's reliance on certain non-prior art was not error because its determinations were supported by substantial evidence even if that art were ignored.  Second, regarding Novartis's arguments concerning the objective indicia of non-obviousness, the opinion notes that the parties had "extensively redacted this portion of the public version of the Board's decision" but the Court had found substantial evidence supporting the Board regardless (perhaps evincing an acknowledgement from the Court that the public deserved to be told the outcome even if the parties' redactions prevented the Court from setting forth the bases for its decision in the opinion.

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Prost, Reyna, and Chen